Senior Director/VP, Data Management

We are seeking analytical and detail-oriented individual, who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols, design and review case report forms, provide input to clinical database development and perform all data management related activities.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

Job Responsibilities include, but are not limited to:

  • Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival

  • Conduct oversight of data management CROs by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards

  • Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)

  • Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA)

  • Coordinate cross functional data review and provide proactively review of data trends and issue resolution

Requirements

  • Bachelor’s degree is required

  • 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry

  • Hand-on knowledge and experience in data management activities, CRF and EDC design, review, and validation from various vendors

  • Knowledge of SDTM and experience in transforming raw data into these standards

  • Knowledge of GCP, ICH, and regulatory requirements

  • Successful track record of working independently in a matrixed organization and providing solutions to emerging problems

  • Excellent interpersonal communication skills, along with organizational skills   

About Context Therapeutics®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.