Who We Are
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Data Management Science (DMS) group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The DMS Operations sub-function is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as: protocol review, Case Report Form (eCRF) development, Data Management Plan development, Data Validation Plan development, requirement specifications, reconciliations, and data quality validation activities.
In the Data Management Operations Study Lead role, the Senior Manager is responsible for all study-related data management activities, including protocol review, eCRF development, Data Management Plan development, Data Validation Plan development, reconciliations, and the delivery of complete, correct, and consistently fit-for-purpose study data sets for statistical analysis.
The Senior Manager may also act as a Program Lead, as needed.
Program Planning and Execution:
- Complete all study Data Management activities and deliverables, including (but not limited to):
- Ensure Data Management colleagues and Data Science colleagues are engaged in study startup activities by facilitating appropriate project management activities, such as kick off meetings, timelines, other relevant communications
- Conduct protocol review and raise any data collection considerations affecting data quality, reliability, or suitability for statistical analysis
- Define Case Report Form (eCRF) in concise, self-explanatory, and user-friendly format. Collaborate with study team colleagues to ensure eCRF completion guidelines/instruction are accurate
- Develop and facilitate approval of Data Management Plan outlining key data management activities and deliverables
- Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan
- Collaborate with Clinical Programming and Database Development colleagues to ensure that database build occurs in accordance with specifications and timelines
- Execute appropriate ongoing/periodic Data Validation activities in collaboration with Clinical Programming, including reviews of data listings, discrepancies, and the related follow-up on management of queries with investigators
- Conduct the identification, investigation, and resolution and/or escalation of study and program data issues, as appropriate
- Oversee and facilitate medical coding activities
- Collaborate with Clinical Programming on the development and execution of data transfer specifications
- Collaborate with Clinical Programming and BioMarin Pharmacovigilance (BPV) on SAE reconciliation activities
- Complete pre-database lock or snapshot checklist activities and related Data Validation meetings with cross-functional stakeholder to approve the DB lock/snapshot go ahead
- Develop and deliver regular updates to leadership on key program risks, issues, and milestones
- Oversee Trial Master File update for all Data Management deliverables
- Ensure compliance with Regulatory Guidelines (e.g., FDA, ICH) across all study-related Data Management activities
- May represent Data Management as a member of the relevant study team (e.g., clinical Study Execution Team (SET) or post-approval Medical Affairs Program Team (MAPT) or Study Team (MAST)
- May lead a Data Working Group to investigate, diagnose, and resolve study data issues; lead the cross-functional review of data management deliverables: CRF, edits checks, DM plan
- May lead all data collection and management-focused meetings with cross-functional partners/stakeholders: Data Science colleagues, GSO, GMAF, CLS, BPV, Translational Science, Project Management, Compliance, and Regulatory
- Participate in Data Analysis and Review Team (DART), when appropriate, to discuss Data Management deliverables and activities
Subject Matter Expertise
- Participate in initiatives aimed at expanding Data Science and Data Management Science capability in a designated area of expertise, such as CDISC/CDASH, local labs, ePRO, imaging, RWE, etc. by building best practices in processes, tools, templates, or other guidance for the subject area
Education & Experience
- PhD or MA degree preferred, or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline
- 3+ years of experience in clinical development, including technical experience within and outside of Data Management, with PhD; 5+ years with MS; 8+ years with BS
- 1 year of people management experience preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.