Clinical Trial Manager

JOB DESCRIPTION: Plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact (supervise, steer etc.) for involved CROs and other external vendors, if applicable Agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence Facilitate communication and ensure adequate collaboration between all involved parties Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.) Participate in teams related to trial conduct (e.g. Clinical Study team, Extended Joint Abbott- CRO Clinical Team, Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting, CRA meeting, Investigator meeting, etc) as applicable Read, review and/or assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicable Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission, etc. Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF): Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary Ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality) Co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites Monitor data c

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 Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data Monitor and interpret key performance indicators (KPIs), metrics, dash

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 External Data Specialist is responsible for managing the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The Senior External Data Specialist will provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, imaging, PK, PD, eCOA, ePRO, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. The Senior External Data Specialist works to ensure departmental SOPs, guidelines, regulatory and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. This position reports to the Manager, External Data. KEY TASKS & RESPONSIBILITIES In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities: Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders. Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues. Communicate to vendors and client issues involving external data transfers, data point issues and validation issues. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time a

OVERVIEW The Medical Coder is responsible for centralized medical coding activities and serious adverse event (SAE) reconciliation, serving as the lead coding resource for assigned clinical trials. This role ensures the accuracy and compliance of coding practices, maintains Medical Coding Guidelines and SAE Plans, and supports the reconciliation of serious adverse events. KEY TASKS & RESPONSIBILITIES ➢ Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors ➢ Perform precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries ➢ Conduct reviews for coding accuracy and consistency reviews including the approval of coded terms and synonym lists ➢ Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources ➢ Generate coding/SAE queries as necessary ➢ Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information ➢ Document coding decisions and justifications for clarity and auditability ➢Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution ➢ Participate in the completion of MedDRA and WHODrug dictionary up versioning workflow activities in alignment with medical coding guidelines ➢ Perform testing of coding tool and deployment of coding/SAE listings in elluminate® ➢ Ensure compliance with eClinical Solutions and industry quality standards, regulations, guidelines, and procedures ➢ Other duties as assigned Education & Experience ➢ Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred ➢ 5+ years’ experience in the Pharmaceutical/Biotechnology industry with medical coding experience us

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 eClinical Solutions is seeking a Consultant - Operational Excellence & AI Transformation to drive highimpact, time-bound transformation initiatives across the organization. This role will focus on identifyingin efficiencies, implementing process improvements, and leveraging AI and automation to enhance operational effectiveness, scalability, and decision-making. The consultant will work closely with crossfunctional teams across global stakeholders to design, prototype, and deploy solutions, while establishing frameworks that can be sustained post-engagement. KEY TASKS & RESPONSIBILITIES Process Transformation & Optimization Assess current workflows across key business functions Identify inefficiencies, redundancies, and improvement opportunities Create process maps, SOPs, and scalable operating frameworks AI & Automation Initiatives Identify high-impact AI and automation use cases across functions Design and prototype solutions using LLMs / AI copilots, APIs and automation tools, Low code / workflow platforms Develop pilot solutions to reduce manual effort, improve turnaround time, enhance accuracy and decision-making Build reusable frameworks and playbooks for automation adoption IT Service Management (ITSM) & ITIL Frameworks Build and operationalize service management processes, aligned to ITIL standards Define and implement ITIL-aligned workflows Establish SLA frameworks, escalation matrices, and service KPIs Recommend improvements to tools and service delivery models Analytics &

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 Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate® platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems software. You will also design and develop reporting programs as needed. KEY TASKS & RESPONSIBILITIES Leading consulting efforts and providing high-level technical consulting services to clients, including configuring the elluminate® platform and overseeing specific projects such as trial configuration, quality control, and project management. Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate® Mapper, and Qlik. Providing technical guidance, training, and support to team members and users on processes, technology, and products. Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. Possessing high-level debugging skills for ETL or analytical issues by referring to the required source data. Demonstrating in-depth knowledge of