PURPOSE OF JOB:   

The Associate Director, Clinical Data Management (CDM) Operations, serves as a leader for all study-team facing activities for a therapeutic area.  The position is responsible for providing operational and technical leadership in all aspects of CDM for clinical trials.  This position functions in an advisory capacity to other functions in terms of the required handoffs to and from CDM.  Additional duties include project management, participation in departmental management and participation on strategic teams for solution development. 

MAJOR DUTIES AND RESPONSIBILITIES:

• Serve as an interdepartmental subject matter expert for the CDM Operations area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance
• Contribute to processes, infrastructure development and staffing to build CDM function, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards such as eCRF and edit check library
• Interface with internal stakeholders including regulatory affairs, program management, and R&D to assess and meet data management needs; represent CDM function in project team activities and meetings
• Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data
• Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable
• Generate data listings or other data review tools for reporting of study metrics
• Contribute to selection of CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment
• Responsible for management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements
• Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc.
• Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives including data collection and data cleaning expectations; develops SOP as needed.

EDUCATION REQUIREMENTS: 

• Bachelor’s degree required. Master’s degree preferred
• Minimum of 8 years of experience in a fast-paced pharmaceutical/biotechnology position facilitating execution of multiple proof of concept, late stage and post-marketing trials simultaneously
• 5+ years of supervisory and management experience
• Strong understanding of the clinical data management process including CDASH and SDTM data formats, and familiarity with physiology, pharmacology, clinical study objectives and methodologies
• Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
• Expert knowledge of industry leading eCRF tools including IxRS and eCOA/ePRO
• Good understanding of database and dictionary structures (e.g., MedDRA)

EXPERIENCE REQUIREMENTS: 

• Commitment to quality programs and data-driven program evaluation
• Excellent interpersonal (multidisciplinary), written and verbal communication skills. Ability to communicate technical information to a non-technical audience
• Expertise in Spotfire or other programming tools preferred
• Established experience with EDC vendors and processes. Medidata Rave preferred
• Extensive knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping
• Experience strategizing and creating data management tools to enhance DM work product
• Thorough knowledge of drug development process from IND to NDA

Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials