Senior Manager / Associate Director, Clinical Data Management

Location
San Diego, California
Posted
Jun 22, 2022
Ref
o5y8jfwO
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Reporting to the Head of Clinical Data Management, the Senior Manager/Associate Director*, Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming and biostatistics. The Senior Manager/Associate Director*, Data Management will ensure the accuracy, consistency, completeness, and high quality of the clinical database. The role will work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders.

*Title commensurate on experience

 Key Responsibilities:

  • Lead clinical data management oversight of outsourced clinical trials for Avidity clinical trials including project management, vendor management, coordination of internal reviews, and approval of day-to-day data management deliverables
  • Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts, and liaising with study management CRO to ensure site training and timely initiation
  • Provide direction and guidance to team members, including consultants and vendors, as well as other functional groups in Data Management area, to achieve/meet corporate goals and milestones
  • Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements
  • Responsible for user acceptance testing, from authoring test plans to executing test scripts
  • Oversee data management activities to maintain consistency across trials; including development and implementation of data collection/review tools, data management documents, data flow metrics, and driving data snapshot/closeout activities
  • Proactively identifies risks and execute risk mitigation strategies; Maintains timely communication with both upper management and cross-functional teams
  • Oversees CRO/Vendor activities to ensure GCP compliance, Avidity quality expectations are met and timelines are adhered to
  • Contribute to process development with focus on efficient, streamlined procedures
  • Contribute to program deliverable timeline creation and project re-forecasting
  • Support data management activities for regulatory submissions
  • Performs additional duties as assigned

Requirements:

  • BS degree in life science or related field with minimum of 7+ years (10+ for Associate Director) of CDM experience in CRO, biotech or pharmaceutical industry; 5+ years' hands-on data management experience
  • Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program
  • Strong vendor oversight experience
  • Experience managing and collaborating with multiple external data providers such as ePRO, central lab, specialty lab and central readers
  • Experience working with eTMF systems and inspection readiness activities
  • Understanding the principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements
  • Expertise with CDISC standards, including CDASH and SDTM; Working knowledge of SAS or SQL preferred
  • Proficiency with Medidata Rave EDC, Clinical Data Repositories and Visualization software
  • Proficient in Microsoft Word, PowerPoint, MS Project, Outlook and Sharepoint
  • Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require
  • Experience in neuromuscular diseases or rare diseases preferred
  • Regulatory submission, audit experience preferred
  • Ability to work well in a team environment both as a leader and a contributor.
  • Excellent communication skills (written and oral) across all organizational levels
  • Collaborative, respectful, agile and transparent work style