Sr. Study Manager/Study Manager, Global Study Operations - US (Also open in UK)Location San Rafael, California Apply
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 BioMarin Global Study Operations (GSO) function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
For assigned study(ies), the Sr. Study Manager (SM) is accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact within GSO for a study. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the GSO study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables. The Sr. SM may be assigned to and is responsible for managing complex early-stage studies, late-stage, pivotal registration, or post approval studies, which requires a greater depth of study execution experience. The Sr. SM plays a greater role in supporting the Program Lead (PL) and/or Program Director (PD) in program wide activities, engaging with leadership, and leading Study Execution Team (SET) activities.
Within the role the candidate is expected to show and have proficiency and experience in the following competencies:
- Decision Making, Strategic Thinking, and Problem Solving
- Influence and Organizational Awareness
- People Management
- Agility and Proactivity
- Communication and Collaboration
- Data Analysis and Interpretation
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
- Overall study execution oversight
- Provide leadership, guidance, and direction to GSO staff assigned to studies
- Facilitate cross-functional Study Execution Team (SET) meetings
- Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans
- Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner
- Provide regular study quality and progress updates to key stakeholders as needed
- Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate
- Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program
- Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth
- Other responsibilities Include:
- Contribute to the Study protocol and Informed Consent Form (ICF) development
- Management of Study Timelines
- Management of CRO and Vendors
- Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)
- Oversight of Drug / Investigational Product (IP) process
- Management of Study Budget
- Oversight of Feasibility, Recruitment and Enrollment
- Oversight of Study Outcome and Data Deliverables
- Lead or participate in program or study-specific projects that have a wider impact
- Collaborate with study managers/cross-functional team members to implement department process change and efficiencies
Education & Experience:
- 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
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.
In the U.S., the salary range for this position is $ 106,600 to $ 159,900 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.