Clinical Data Manager (Contract)

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. This role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR). This position will also manage Contract Research Organizations (CROs) providing programming support, and eSubmission package planning, execution, and quality checks of package components for

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. Beacon is hiring a Senior Commercial Contracts Manager to own our contracting process end to end. We are looking for a highly experienced contracts professional with a paralegal or contracts administration background. What matters most is your negotiation expertise, not the credential behind it. You will report directly to the General Counsel and be Beacon’s primary point of contact for drafting, negotiating, and closing customer and supplier agreements, including pharma and biopharma collaboration agreements, clinical trial services agreements, home sleep testing partnerships, and vendor and supplier contracts. Because patient EEG and sleep data is Beacon’s core commercial asset, you will need to be fluent in data rights: ownership, licensing scope, and secondary-use restrictions. You should also have a working knowledge of the HIPAA and GDPR issues that commonly arise in life sciences and health data contracting. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs located in Boston and New York. What You’ll Do Own the full contract lifecycle for customer and vendor agreements: drafting, negotiation, redlining, and execution from initial term sheet through signature and integration with Beacon systems. Conduct negotiations on pharma and biopharma collaboration agreement

Job Title: Project Manager Department: Biometrics/Project Management Responsibilities: Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. Serves as the primary liaison between clients, vendors, and project teams. Promotes team communication and cross functional collaboration in order to promote team spirit. Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. Coordinates and leads team meetings. Creates and distributes agendas and minutes. Generates and maintains timelines, milestones, and action items. Manages project financials; estimates monthly accruals and initiates timely invoice generation. Identifies change orders items. Oversees issues and facilitates issues resolution, and escalates, when needed. Identify risks, mitigation, maintenance and resolution. Ensures training required internally and by sponsor is completed. Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. Provides performance feedback for project team and managers. Supports business development activities (RFPs and RFIs) and governance activities, when required. Performs other tasks as assigned by Sr. PM staff. Skills and Qualifications: Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. Possesses solid knowledge of Biometrics services and inter-dependencies. Knowledge of FDA regulations, drug development and PM processes. Good understanding of ICH/GCP guidelines. Strong communication s

Job Title: Project Manager Department: Biometrics/Project Management Responsibilities: Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. Serves as the primary liaison between clients, vendors, and project teams. Promotes team communication and cross functional collaboration in order to promote team spirit. Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. Coordinates and leads team meetings. Creates and distributes agendas and minutes. Generates and maintains timelines, milestones, and action items. Manages project financials; estimates monthly accruals and initiates timely invoice generation. Identifies change orders items. Oversees issues and facilitates issues resolution, and escalates, when needed. Identify risks, mitigation, maintenance and resolution. Ensures training required internally and by sponsor is completed. Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. Provides performance feedback for project team and managers. Supports business development activities (RFPs and RFIs) and governance activities, when required. Performs other tasks as assigned by Sr. PM staff. Skills and Qualifications: Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. Possesses solid knowledge of Biometrics services and inter-dependencies. Knowledge of FDA regulations, drug development and PM processes. Good understanding of ICH/GCP guidelines. Strong communication s

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients. The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners . ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Main Job Tasks and Responsibilities: Safety and PV System Management Perform the quality check of the PV cases and ensure that the English translation has been properly performed. Keep up to date a local tracker of the individual safety reports. Be the subject matter expert at local level on the case management activities. Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams. Establish and maintain local indicators on the compliance of the safety reports submission. Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings. Perform regulatory monitoring for impact on vigilance activities and responsibilities. Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). Maintain overs

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