Senior Clinical Implementation Manager Jobs

Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities such as implementation of quality control process. Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries. Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate. Maintain PV expertise and understanding of international safety regulations and guidelines. Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines. Provide timely feedback to case processors on the errors/ discrepancies noted. Assist in training/mentoring of other case processing/medical review personnel as necessitated. Adapt to different client case processing conventions and multi-task as per business needs. Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement. Participate in organizational activities to meet objectives suitable for the role/area of expertise. Candidate Profile: Me

Position Summary Join K Health as a pioneering clinical leader and play a key role in transforming healthcare delivery. At the forefront of innovation, our AI-powered tools are redefining standards for high-quality, efficient care. In collaboration with leading hospital systems across the country, we are expanding access to healthcare through state-of-the-art Virtual Comprehensive Care Clinics. K Health is seeking an innovative, technology-forward Medical Director to serve as a senior member of the Medical Leadership Team and help lead the next generation of AI-enabled healthcare delivery. Reporting directly to the Chief Medical Officer, this executive physician leader will oversee clinical operations for a 24/7 virtual care platform that provides integrated primary care, behavioral health, and acute care services through text and video-based interactions. Join us in shaping the future of healthcare and making a meaningful impact on the lives of patients nationwide. Responsibilities and Essential Duties Become an expert in our AI based care delivery model, which uses data driven models to provide quality care efficiently Develop a comprehensive understanding of our clinical practice within our consumer and partnership clinics Owner of clinical policy and regulatory oversight within Virtual Clinic Collaborate with Practice Manager to assess opportunities for continued operational improvement Participate in the customization, development, design, standardization, implementation, and review of medical operations, protocols, and data to ensure operational accuracy and efficiency Lead a partnership clinic, from development to launch, be accountable for the oversight and management of clinic operations and practicing clinicians Provide clinical expertise to both internal teams (operations, product, medical, regulatory, non-clinical, marketing, and data science) and external teams to ensure that clinical needs and business strategies are met Share regular updates and

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Senior Software Developer will work closely with Product Manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities. KEY TASKS & RESPONSIBILITIES Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices. Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques. Experienced in data integration through extracting, transforming, and loading (ETL) data from various sources. Good at Data transformation, the creation of QVD files and set analysis. Data Modelling using Dimensional Modelling, Star schema and Snowflake schema. Strong SQL skills (SQL Server) to validate the Qlik sense dashboards and to work on internal applications. Knowledge on deploying of Qlik Sense application using Qlik Management Console (QMC) is a plus. Work with Implementation consultants (ICs), product manager and clients to gather the requirements. Configuration, migration, and support of Qlik Sense applications. Thoughtful implementation of Qlik Sense best practices for efficiency and re-usability. Research and utilize new technologies. Collaborate with the Software Quality Assurance (SQA) team to test the applications functionality. Ensure compliance with eClinical Solutions/industry quality standards,

Opportunity Overview: We are seeking a Senior Software Engineer - AI to join our Engineering team. In this role, you will build the intelligent agents and applications serving health insurance plans covering over 15 million people. You'll partner closely with product, data science, and clinical teams to build the foundation that transforms how clinical intelligence is delivered at scale. This is an opportunity to make a direct impact on healthcare outcomes while working with modern technologies in a fast-paced, collaborative environment. What you’ll do: Agent Development : Participate in the development, evaluation, and deployment of Cohere’s AI-powered agents and applications. Data & Retrieval Architecture : Design data and retrieval architectures that give AI agents the right context across diverse healthcare sources. Hands-On Engineering : Design, review, and own high-quality agentic code — leading releases, production deployments and on-call support. Cross-Functional Collaboration : Work closely with ML/DS teams, product teams, and architects to understand requirements and ensure systems meet business needs. Security & Compliance : Ensure all agentic components comply with healthcare security and privacy regulations (e.g., HIPAA) and adhere to industry best practices for security. Agile Development : Contribute to sprint planning, execution, and retrospectives, driving efficiency and velocity within the engineering team and collaborating closely with stakeholders to align with product goals and business priorities. ISMS roles and responsibilities: Good knowledge of Information practices. Assist the manager in all the information security activities implementation and maintenance process. Ensuring the team and imparted with Competence related to Information security Responsible for implementation of security policies and procedures and report any issues to the Information Security Manager. Required Qualifications: Must-haves Bachelor’s degree

Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company) Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day. About The Role The Laboratory Systems Scientist at Foresight Diagnostics will be responsible for supporting laboratory operations infrastructure as a technical SME. The Laboratory Systems Scientist will collaborate with research, development, clinical, bioinformatics, software, operations, regulatory, quality, to enable laboratory system development, implementation and maintenance. This is a full-time position based in Colorado working standard business hours in a startup company, that will require the flexibility to work diverse schedules, including evenings, weekends, and holidays for critical deliverables. This position will report to the Senior Manager, Operational Excellence & Process Engineering. What You Will Do Operate as a technical SME and stakeholder dedicated to development, implementation, and release testing for laboratory non-product software and automation solutions. Collaborate with the Program Management and laboratory leade

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. The purpose of the Center Medical Director role is to lead the clinical team at their center in providing the best patient care and a great place to work in order to keep patients happy, healthy and out of the hospital. The Medical Director will practice primary care in our clinics alongside their provider colleagues at 80% clinical time and 20% administrative time. The CMD will have mission-critical leadership responsibilities, which include setting an example for how thoughtful primary care is practiced, serving as a formal mentor, coach, and advisor to providers in clinics, and participating in critical organizational-wide strategic initiatives. Core Responsibilities: The Center Medical Director is the medical leader for his/her center. In this role the CMD will have the following responsibilities: Support of Organizational Strategy Work in tight collaboration with the Practice Manager and Outreach Manager/Director to achieve our organizational objectives: Best Care Anywhere Unmatched Patient Experience Exceptional Growth Great Place to Work and Leader in DE&I Drive implementation of strategic initiatives. Follow direction from regional leadership (regional medical director or senior medical director) in collaboration with CMDs in the region to implement regional priorities and reach regional objectives.<br

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Position Overview The Senior Clinical Laboratory Scientist will be responsible for performing moderate and high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, assisting Laboratory Leadership with advanced laboratory duties, and complying with all applicable local, state, and federal laboratory requirements. The Senior Clinical Laboratory Scientist will continually display excellent initiative in all aspects of their work, contribute to projects and discussions in addition to daily laboratory testing and consistently performing to high standards. Leadership is demonstrated in technical troubleshooting of laboratory instrumentation and processes as well as laboratory quality improvements, health and safety, and training of laboratory staff. Essential Duties include but are not limited to : Perform moderate and highly complex laboratory tests, procedures, and analyses according to the laboratory’s standard operating procedures with minimal supervision. Perform, review, and document laboratory quality control procedures. Identify potential problems, determine potential solutions, and take appropriate action in order to maintain a high level of quality in test processes and results. Achieve and maintain competency on laboratory tasks. Participate in research, validation, and/or implementation of new procedures and/or technologies. Mainta

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior Statistical Programmer to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Senior Statistical Programmer to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Main Job Tasks The Senior Statistical Programmer is a delivery-focused role responsible for leading and supporting aspects of the programming effort to deliver technical programming and information components of a project. The position requires strong technical skills, thorough knowledge of the industry, and demonstrated experience leading statistical programming activities and providing technical guidance to other programmers . The individual should be able to independently perform programming tasks, oversee programming deliverables, and effectively collaborate with cross-functional teams and external vendors. Responsibilities Programing for clinical trials: Program and validate derived datasets, tables, figures, listings. Process data from the external sources. Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations. Oversee programing work/deliverables from CROs. Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages. Electronic submissions: Program and va

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior Statistical Programmer to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Senior Statistical Programmer to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Main Job Tasks The Senior Statistical Programmer is a delivery-focused role responsible for leading and supporting aspects of the programming effort to deliver technical programming and information components of a project. The position requires strong technical skills, thorough knowledge of the industry, and demonstrated experience leading statistical programming activities and providing technical guidance to other programmers . The individual should be able to independently perform programming tasks, oversee programming deliverables, and effectively collaborate with cross-functional teams and external vendors. Responsibilities Programing for clinical trials: Program and validate derived datasets, tables, figures, listings. Process data from the external sources. Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations. Oversee programing work/deliverables from CROs. Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages. Electronic submissions: Program

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio . Position Summary The Senior Director, Quality (SD) reports to the Chief Technical Officer and is responsible for all aspects of the quality organization including support and oversight for all internal and external GxP operations inclusive of clinical quality assurance (CQA). As the leader of the quality function, the SD establishes and maintains a culture of quality across the organization and is responsible for overseeing development, implementation, and continuous improvement of all quality systems to ensure that all products, processes, and operations comply with applicable regulatory requirements. The SD is ultimately responsible and accountable for critical decisions that directly impact product integrity, patient safety, regulatory compliance, and business continuing. The SD works with both internal and external stakeholders to manage timelines, meet internal deliverables and develop a best-in-class quality organization. This position develops, leads, and coaches the teams responsible for quality systems, quality control, document control, quality assurance, clinical quality, and compliance. The SD responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with applicable GxPs. Additional responsibilities include team building, ca

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff! This role will require onsite leadership in Cambridge, MA. What you’ll do Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation. Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance. Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ). Establish and execute a comparability strategy for pivotal process changes. Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation. Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections. Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Dev

Work Flexibility: Field-based Associate Sales Representative – Injury/Infection Prevention As an Associate Sales Representative, you will play a key role in supporting the sales team by promoting Stryker's Sage products, with a focus on Injury and Infection Prevention solutions, to healthcare providers. You’ll assist with engaging product demonstrations, contribute to managing customer relationships, and provide exceptional support to ensure client satisfaction. Additionally, you’ll participate in training programs, attend industry events, and collaborate with the sales team to help achieve business goals. This position serves as an excellent opportunity to gain valuable experience and advance into a more senior sales role within Stryker. What you will do Promote Sage Products to nurses/clinicians and appropriate hospital staff while providing excellent customer service and developing customer relationships. Follow extensive product training, to be able to tailor promotional messages based upon knowledge of the customer, advise on appropriate product selection, answer customer questions about product functionality and distinguish Sage’s products from competitors. Assist in hospital surveys as well as post-sale implementation and training including ensuring customer adoption and satisfaction. Focus on customer satisfaction by demonstrating teamwork and empowerment, solving problems through a consultative approach, operating with honesty and integrity and providing a highly responsive and unsurpassed level of customer service. Assist in preparation and operation of trade shows, conventions and clinical meetings. Adhere to all facility protocols and pertinent Occupational Safety and Health Administration (OSHA) guidelines when conducting product evaluation. </b

Work Flexibility: Field-based Associate Sales Representative – Injury/Infection Prevention As an Associate Sales Representative, you will play a key role in supporting the sales team by promoting Stryker's Sage products, with a focus on Injury and Infection Prevention solutions, to healthcare providers. You’ll assist with engaging product demonstrations, contribute to managing customer relationships, and provide exceptional support to ensure client satisfaction. Additionally, you’ll participate in training programs, attend industry events, and collaborate with the sales team to help achieve business goals. This position serves as an excellent opportunity to gain valuable experience and advance into a more senior sales role within Stryker. What you will do Promote Sage Products to nurses/clinicians and appropriate hospital staff while providing excellent customer service and developing customer relationships. Follow extensive product training, to be able to tailor promotional messages based upon knowledge of the customer, advise on appropriate product selection, answer customer questions about product functionality and distinguish Sage’s products from competitors. Assist in hospital surveys as well as post-sale implementation and training including ensuring customer adoption and satisfaction. Focus on customer satisfaction by demonstrating teamwork and empowerment, solving problems through a consultative approach, operating with honesty and integrity and providing a highly responsive and unsurpassed level of customer service. Assist in preparation and operation of trade shows, conventions and clinical meetings. Adhere to all facility protocols and pertinent Occupational Safety and Health Administration (OSHA) guidelines when conducting product evaluation. </b

Work Flexibility: Field-based Associate Sales Representative – Injury/Infection Prevention As an Associate Sales Representative, you will play a key role in supporting the sales team by promoting Stryker's Sage products, with a focus on Injury and Infection Prevention solutions, to healthcare providers. You’ll assist with engaging product demonstrations, contribute to managing customer relationships, and provide exceptional support to ensure client satisfaction. Additionally, you’ll participate in training programs, attend industry events, and collaborate with the sales team to help achieve business goals. This position serves as an excellent opportunity to gain valuable experience and advance into a more senior sales role within Stryker. What you will do Promote Sage Products to nurses/clinicians and appropriate hospital staff while providing excellent customer service and developing customer relationships. Follow extensive product training, to be able to tailor promotional messages based upon knowledge of the customer, advise on appropriate product selection, answer customer questions about product functionality and distinguish Sage’s products from competitors. Assist in hospital surveys as well as post-sale implementation and training including ensuring customer adoption and satisfaction. Focus on customer satisfaction by demonstrating teamwork and empowerment, solving problems through a consultative approach, operating with honesty and integrity and providing a highly responsive and unsurpassed level of customer service. Assist in preparation and operation of trade shows, conventions and clinical meetings. Adhere to all facility protocols and pertinent Occupational Safety and Health Administration (OSHA) guidelines when conducting product evaluation. </b

Work Flexibility: Field-based Associate Sales Representative – Injury/Infection Prevention As an Associate Sales Representative, you will play a key role in supporting the sales team by promoting Stryker's Sage products, with a focus on Injury and Infection Prevention solutions, to healthcare providers. You’ll assist with engaging product demonstrations, contribute to managing customer relationships, and provide exceptional support to ensure client satisfaction. Additionally, you’ll participate in training programs, attend industry events, and collaborate with the sales team to help achieve business goals. This position serves as an excellent opportunity to gain valuable experience and advance into a more senior sales role within Stryker. What you will do • Promote Sage Products to nurses/clinicians and appropriate hospital staff while providing excellent customer service and developing customer relationships. • Follow extensive product training, to be able to tailor promotional messages based upon knowledge of the customer, advise on appropriate product selection, answer customer questions about product functionality and distinguish Sage’s products from competitors. • Assist in hospital surveys as well as post-sale implementation and training including ensuring customer adoption and satisfaction. • Focus on customer satisfaction by demonstrating teamwork and empowerment, solving problems through a consultative approach, operating with honesty and integrity and providing a highly responsive and unsurpassed level of customer service. • Assist in preparation and operation of trade shows, conventions and clinical meetings. • Adhere to all facility protocols and pertinent Occupational Safety and Health Administration (OSHA) guidelines when conducting product evaluation. What you need Required:</b