Clinical Data Management Lead

San Francisco, CA, United States
May 23, 2019
Clinical, Clinical Data
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Clinical Data Management Lead will oversee the clinical data management function at GBT. Reporting to the Senior Director, Biometrics, you will work closely with Biometrics, Clinical Operations, Clinical Science, and Pharmacovigilance teams to ensure data quality of GBTs clinical trials. As an individual contributor, the successful candidate will be both a strong hands-on executor as well as strategic manager of internal and external partners.

Essential Duties and Responsibilities:
  • Provides leadership, mentorship to internal data management staff
  • Provides leadership and direction for outsourced activities
  • Oversees all assigned clinical trials to ensure data quality, integrity and timeliness
  • Works closely with the Study Management Team to set study goals and objectives
  • Responsible for managing, leading and overseeing DM operational activities by ensuring compliance with the corporate timelines and scope of work
  • Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standards
  • Supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal resources and/or vendors
  • Lead vendor and technology evaluation, qualification and selection
  • Manage reconciliations between clinical and safety databases
  • Budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting
  • Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget
  • Creates and maintains positive, cohesive work environment
  • Responsible for the global standardization of DM processes and process improvement and efficiency

Database Design:
  • Collaborates with external database developer on the appropriate design of the database
  • Annotates/or reviews CRFs for database developer to use in building the database
  • Writes/or reviews the consistency checks for studies to be programmed in the database
  • Develops/or reviews screen test scripts and consistency check scripts to validate the database
  • Oversees eCRF unit testing and database user acceptance testing
  • Writes/or reviews the Data Management Plan (DMP) and eCRF Completion Guidelines for each new protocol; ensures the DMP and DEG are updated, when appropriate, for each new protocol amendment
  • Ensures appropriate metrics reports and data review listings are available for the study team

Discrepancy Management:
  • Develop internal data review plan
  • Oversee data query process for studies in EDC
  • Ensure database is clean and all queries resolved after data have been entered

Database Lock:
  • Interacts with Biometrics Team to transfer data for analysis
  • Reviews and prepares data for study team review to ensure data integrity prior to locking
  • Ensures SAE reconciliation is completed
  • Ensures the clinical database is reconciled with all outside sources of data
  • Ensures AEs, medical history, and concomitant medications are coded appropriately (e.g. MedDRA, WHO Drug Dictionary), reviewed and approved

Additional Responsibilities:
  • Recommends clinical data management processes and assists to develop department SOPs and Guidelines

  • At least 10 years of experience in Clinical Data Management and a minimum of 4 years prior management experience of external vendors
  • Working knowledge of global clinical trials
  • Thorough knowledge of applicable regulatory rules and ICH guidelines
  • Demonstrated proficiency in data management processes
  • Strong attention to detail
  • Previous CDISC experience is required
  • Proficient in the use of clinical data management systems (e.g. Medidata Rave, InForm)

Fit with GBT culture
  • Ability to build strong relationships with co-workers across functions
  • Ability to function at a high level in a team setting whether leading a cross-functional group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.