Sr. Clinical Data Manager

Role Summary

The Sr. Clinical Data Manager will handle detailed data management issues for all phases of clinical trials (Phase 1-3) including oversight of CRO data management activities and, as needed/requested, provide support to other functional areas within Akebia. The Sr. Clinical Data Manager will be recognized as a leader by their project team. Location: Cambridge, MA.

Responsibilities

• Contribute to the decision-making process involving data management (DM) issues for large or complex clinical studies. Communicate how DM decisions impact other functional areas and the company as a whole
• Provide oversight and participate in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design; this may include the performance of user acceptance testing.
• Ensure completeness and accuracy of all study documentation, may include the need to perform eTMF quality checks. Coordinate and participate in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
• Address/respond to data issues, as needed, identified by cross-functional team members
• Apply experience and education to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities to meet business needs
• Develop and implement changes to DM guidelines and quality processes to ensure clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions by working with lead CRO data manager or equivalent
• Develop/utilize study metrics to monitor quality, project status, activities and budget and work with Manager to identify trends and provide updates/recommendations to Sr. Management on opportunities for improvements; For some studies, this may include the generation, review and/or follow up, as needed, on study level operational performance and quality metrics
• Assist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation or perform validation.
• Ensure that optimal relationships are developed with internal customers/colleagues and with new or existing strategic partners/vendors

Qualifications

• Required: BA/BS in a scientific discipline
• Required: 7+ years of experience (with at least 4 years as lead) as a Data Manager in a CRO or pharmaceutical/biologics/biotechnology company
• Preferred: Experience as lead CDM managing studies from start-up through close-out (including data management activities related to study conduct, study completion and archiving of study materials)
• Preferred: Experience in a pharmaceutical/biologics/biotechnology company must include management or oversight of outsourced CDM activities
• Preferred: Comprehensive understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) and of linkages with tasks and responsibilities of other functions
• Preferred: Capable of prioritizing individual and CRO/Vendor tasks based on timelines and study needs
• Preferred: Ability to use metrics to determine project status, monitor internal/external DM team progress and plan for project resources and monitor project budget
• Preferred: Ability to communicate data management standards, developments, and challenges in an accurate, concise, consistent, organized and grammatically/situationally correct manner to both internal and external audiences
• Preferred: Ability to propose areas for development or process improvement and assist with staff compliance
• Preferred: Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving
• Preferred: A demonstrated proficiency in efficient database and/or SAS dataset design
• Preferred: Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
• Preferred: Ability to prioritize and effectively manage several large projects simultaneously
• Preferred: Capacity to work with little or no supervision with accuracy and thoroughness
• Preferred: Excellent written and oral communication skills

Education

• BA/BS in a scientific discipline

Skills

• Proficiency in efficient database and/or SAS dataset design
• Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
• Excellent written and oral communication skills
• Ability to prioritize and effectively manage several large projects simultaneously
• Capacity to work with little or no supervision with accuracy and thoroughness