The Position

The Manager, Clinical Data Management Operations, leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The assigned clinical trial(s) may be high complexity or high risk. The position is accountable for ensuring study launch, conduct, and closeout are performed according to quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management.

Responsibilities

• Serve as the 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
• Lead the following data management activities for multiple clinical development programs: Database transfer, CRF development, Database specifications, User acceptance testing, Query resolution, Data review, Database lock
• Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
• Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission
• Generate data listings or other data review tools for reporting of study metrics
• 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; develops SOP as needed
• Lead or contribute to the development and implementation of growing departmental policies, standards and process improvement initiatives

Requirements:

• Bachelor's degree
• Minimum of 5 years of experience in a fast-paced pharmaceutical/biotechnology position facilitating execution of multiple proof of concept, late stage and post-marketing trials simultaneously
• 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
• Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
• 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
• Knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping
• Thorough knowledge of drug development process from IND to NDA
• Good understanding of database and dictionary structures (e.g., MedDRA)
• Established experience with EDC vendors and processes

Preferred:

• Master's degree
• Supervisory experience
• Medidata Rave experience
• Expertise in Spotfire or other programming tools