Sr. Manager, Data Management OperationsLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Data Management Operations Study Lead 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 BioMarin Senior Manager will support leadership in the development of Data Management Operational objectives and work plans and will work closely with functional management to obtain review and buy-in to these plans. The Senior Manager will work collaboratively in a cross functional environment on a diverse range of topics that require in-depth Data Management and Clinical Development knowledge, understanding of industry trends and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership.
The Sr. Manager responsibilities may vary depending upon study lifecycle and may include all or part of the following:
Clinical study data deliverable development and execution
- Complete all study data management activities and deliverables including (but not limited to):
- Ensure Clinical Data Management colleagues and Biometrics colleagues are engaged in study startup activities by facilitating appropriate project management activities such as kick off meetings, timeline other relevant communications
- Conduct Protocol review and raise any data collection considerations affecting data quality, reliability or suitability for statistical analysis are addressed
- 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 a 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 to specification 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 delivery regular updates to leadership on key program risk, 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 CDM activities
- May represent Clinical Data Management / Data Management as a member of the relevant study team (e.g., clinical Study Execution Team (SET)
- May lead a Data Working Group to investigate, diagnose, resolve study data issues and problems; 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: Biometrics colleagues, CLO, Biometrics colleagues, BPV, 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 Biometrics and Data Management 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
- Degree in Statistics, Computer Science, or Life Science.
- PhD/Masters preferred; Bachelors acceptable with relevant experience
- 3 + year experience with PhD; 5+ years with Master’s or 8+ with bachelor’s degree
- Relevant clinical development experience inclusive of technical and management experience within and outside of Clinical Data Management
- 1 year of line 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.