Sr Manager, Clinical Operations - United States
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BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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 Sr. Manager is an experienced team lead within clinical operations, deploying communications, teamwork, and leadership skills to ensure successful clinical trial execution.
The Sr. Manager holds the role of CLO Study Lead on one moderate complexity study or on multiple studies. In this role, this person leads all day-to-day Clinical Operations functional activities associated with the execution of a clinical trial. The Sr. Manager is responsible for oversight of the CLO study team, the Clinical Research Organizations (CROs), and third party vendors associated with the study. S/he is capable of overseeing and executing on all delegated tasks associated with clinical trial execution.
In the case of a global, multi-country study, the Sr. Manager, may have an opportunity to oversee and develop several Regional Study Lead personnel that are leading region specific activities.
Following demonstrated success in the Study Lead role, the Sr. Manager may have the opportunity to take on the Study Team Lead role for one or more low complexity studies.
Study Planning & Management
- Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin SOPs, ICH and FDA and other Health Authorities (HAs))
- Oversee study feasibility assessment activities (if applicable)
- Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
- Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
- Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan
- Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
- Provide CLO study activity timeline and budget inputs to overall Study Team timeline and budget
- Lead cross-functional effort to define enrollment strategy and plan for the study
- Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
- Provide study status updates to the Study Team and Study Team Lead
- In collaboration with appropriate teams, oversee and approve vendor evaluation and selection
- Oversee day-to-day management of CRO and vendors’ contracted activities as per oversight plans
- Work with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure
- Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants
- Plan and deliver IM in collaboration with other key stakeholders
Enrollment and Maintenance:
- Ensure adherence to study enrollment strategy and plan
- Ensure adherence to monitoring plan
- Ensure adherence to monitoring oversight SOP
- Ensure timely site payments
- Partner with Patient Advocacy to manage patient travel, housing and associated management of patient costs
- Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
- Coordinate and oversee data listing reviews
- Ensure timely delivery of clinical documents for the CSR and appendices
- 8 years of pharmaceutical industry experience
- 6 years of experience in clinical research
- 2 or more years of line management experience
- Previous experience working in global environment
- History of successfully developing effective relationships with outside vendors and CROs
- Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
- Demonstrated skills in negotiation, multi-tasking, organization and decision making
- Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
- Ability to travel to global sites required.
- Prior experience working on cross-functional teams in a lead capacity
BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
Work Environment/Physical Demands
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Rare Opportunities. Personal Impact.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.