Senior Manager, Clinical Data Management

Myokardia South San Francisco , CA 94080

Posted 6 months ago


Seeking a Senior Manager, Clinical Data Management to join the Clinical Data Management group within the Biometrics function. We are seeking a highly-motivated, quality-focused individual to work collaboratively in a fast-paced, cross-functional team environment. The Sr. Manager, CDM will oversee clinical data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals. This individual will play a key role in ensuring complete, accurate, high quality clinical data for outsourced trials. This position will report to the Head of Data Management.


  • Oversee clinical data management (CDM) activities across multiple studies.

  • Represent CDM in cross-functional meetings.

  • Ensure DM project deliverables are completed on time and in accordance with quality standards and requirements from study start-up through study closure/archival.

  • Establish and maintain strategic business relationships with CDM vendors; apply effective vendor management throughout the study.

  • Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.

  • 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.

  • Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources.

  • Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements.

  • Participate in the RFP process including the evaluation of potential vendors.

  • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.

  • Perform supplemental data reviews according to the data quality checks outlined in the data validation specifications or Clinical Data Review Plan (CDRP).

  • Participate in reviews of blinded TFL output prior to final database locks.

  • Report query trends and data/query/SDV metrics to the Study Management Team (SMT).

  • Participate in the development of EDC custom report specifications or SAS Clinical Programming report specifications as needed.

  • Prioritize projects and coordinate data management activities in support of corporate goals and objectives.

  • Participate in the development and/or enhancement of CDM department standards, operational procedures and best practices.

  • Assist with strategic planning activities for the CDM department and participate in the implementation of new departmental initiatives.

  • Address the business needs of CDM functional customers.

  • Demonstrate a commitment to company values: Patient First, Passion for Science, Success Together, Imagine and Innovate, and Lifelong Learning.



  • Minimum of a Bachelor of Science degree in a scientific discipline or equivalent college program.


  • 5+ years clinical data management experience in the pharmaceutical/biotech or CRO setting.

  • 5+ years of hands-on Electronic Data Capture (EDC) experience

  • Experience running Ph1-Ph3 clinical trials, both directly (in-house) and outsourced to CRO vendors.

  • Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines.

  • Experience with SAS or SQL programming techniques with clinical data management application a plus.


  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.

  • Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities.

  • Ability to thrive in a fast-paced environment and adapt to changing business conditions with a "can-do" attitude.

  • Ability to work effectively in both a team setting and independently.

  • Strong interpersonal, organizational, and communication (written and verbal) skills.

  • Ability to multitask, prioritize and coordinate activities strategically in support of corporate goals and objectives.

  • Desire to be part of a values based, highly innovative cardiovascular company aimed at transforming the lives of patients and their families.

  • Willing to travel if required.

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Senior Manager, Clinical Data Management