Associate Director, Clinical Data Management
About The Position
Joining a small but highly effective Clinical Data Management team to support leading and overseeing all data management activities for clinical studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines. The Associate Director, Clinical Data Management will represent Compass Data Management in the USA, providing additional time zone coverage for international trials and acting as the Data Management SME in the US for Compass team members, external vendors and regulatory interactions. Under the direction of the UK head of Clinical Data Management, the Associate Director, Clinical Data Management is responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF).
Requirements
- Bachelor's degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience
- A minimum of seven (7) years of clinical data management experience in the pharmaceutical or Clinical Research Organization setting
- Proven track record of strong project management skills and experience managing data management activities
- Experience in vendor selection, partnering, and management
- Expert understanding of clinical data lifecycle, including database design, data structure, database development and testing, query management, data quality review, and database lock procedures
- Advanced working knowledge of data collection standards including CDISC, CDASH and experience with medical coding dictionaries (MedDRA and WHODrug)
- Expert knowledge of 21 CFR Part 11 regulations and regulatory submission requirements
- Expert knowledge of clinical data collection systems including EDC, eCOA and other data collection technologies
- Excellent written and verbal communication skills
- Expert understanding of ICH, GCP, and GDP guidelines including previous experience of supporting audits and regulatory inspections
Nice To Haves
- Late stage development (Phase III) and NDA experience are preferred
Responsibilities
- Contribute or lead development of process initiatives including, DM SOPs, Work Instructions, best practice standards (including data collection standards and implementation of advanced data review technology (e.g. analytic reviews, implementation of AI)
- Accountable and responsible for ensuring the delivery of high-quality data management deliverables and activities from protocol review through database closure and archiving
- Lead design of high-quality EDC CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints
- Lead the development of data set-up integration needs for eCOAs, ePROs, eConsent and other data collection technologies as required by the protocol
- Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines
- Perform, and/or oversee the complete and accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites
- Identify and implement the most appropriate study data management study status/KPIs; analytic checks, data integrity checks and reports to ensure data integrity across Compass portfolio
- Lead data management function in ongoing study CRO vendor selection, qualification, evaluation and oversight
- Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection
- Support or lead data management function for submissions, audits and regulatory inspections as required
- Leverage project management skills to support and oversee multiple projects outsourced and work in a cross-functional team environment
- May include line management of data management reports
- Perform other duties and responsibilities as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
