Manager, Clinical Operations
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 Operations (DSO) 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 Clinical Operations Manager takes on a leadership role in clinical operations study teams to ensure the highest quality of clinical operations deliverables.
The Clinical Operations Manager holds the role of CLO Study Lead. In this role, s/he leads all day-to-day Clinical Operations functional activities associated with the execution of clinical trials. The Manager is responsible for oversight of the CLO study team, as well as the Vendor Management of the Clinical Research Organizations (CROs), and any third party specialty vendors associated with the study. S/he is capable of overseeing and executing on all delegated tasks associated with clinical trial execution, including an up-to-date eTMF and a constant state of Inspection Readiness.
A Manager may also have the opportunity to take on a Regional Study Lead role on highly complex global multi-country studies. For details, refer to the Regional Study Lead role description.
Following demonstrated success in the Study Lead role, the Manager may have the opportunity to take on the Study Team Lead role for low complexity studies. For details, refer to the Study
I. 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
2. 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
3. Vendor Management
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
4. Study Conduct Startup:
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
5. 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
Work closely with specialty vendors to ensure samples are being received and analyzed according to study team/protocol expectations
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
7. Cross- Functional Representation
Act as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teams
Ensure CLO responsibilities for any cross-functional deliverables are met throughout the study, including study close-out and delivery of CLO related appendices for finalization of CSR
Oversee, train and mentor junior study team CRAs and CTAs on study.
Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality and budget.
Manage protocol deviation reviews in collaboration with CLS
Provide forecast for clinical supply, including ancillary supplies and comparator drugs
Contribute expertise to departmental and cross-functional process improvement activities
Oversee eTMF maintenance
Keep team driving to be in a state of constant Inspection Readiness
8 years of pharmaceutical industry experience
6 years of experience in clinical research
2 or more years of line management experience (strongly preferred)
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.
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.