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Independent Research Manager (Temporary)

Location San Rafael, California
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.

The Independent Research Manager will manage day-to-day activities associated with the execution of the Global Independent Research (IR) Program at BioMarin and provide Project Management support to one or more additional Medical Affairs project teams.

RESPONSIBILITIES: 

Manage and oversee the Global Independent Research process

Coordinate and complete all operational activities required for approved study startup, ongoing tracking, and closeout in collaboration with global medical field staff. Actives include but are not limited to:

-Fair Market Value analysis of clinical study budgets

-Liaising with sites and internal legal staff to facilitate contract negotiations.

-Protocol and ICF review

-Regulatory document review

-Debarment checks

-Tracking milestone payments, submitting invoices and financial accruals

-Maintaining IR-related study files; working with field staff to collect and maintain regulatory documentation; performing periodic audits of IR-related tracking systems and documents.

Partner with the MAF team members to anticipate/identify potential problems with study activities and develop and implement corrective actions.

Manage and track the Global IR program budget.

IR study database and application system owner.

Generate and distribute periodic reports and metrics related to the program.

Administer and facilitate program applications and review.

Administer monthly committee meetings.

Ensure compliance with established procedures; update procedures as directed; liaise with Legal, Regulatory, Supply Chain, Packaging Ops, PV, Medical Directors, Medical Science Liaisons, and other stakeholders as required for successful compliant execution of the program.

Deliver IR program training to new hires and ongoing as needed. 

Project Management Support for MAF Project Team

Scheduling meetings, agenda and minutes, project milestone tracking.

Additional support and assignments as needed

Other duties as assigned

  • Minimum 3-5 years of experience in the pharmaceutical industry or academia in clinical trials, as a CRA (Clinical Research Associate) or Research Coordinator, with research management, clinical trial financial/legal administration, medical information, or investigator-initiated research programs.
  • Experience in effectively managing multiple tasks and projects.
  • Ability to self-motivate and work independently to drive program forward.
  • Good working knowledge of ICH & GCP, Regulatory and Healthcare Compliance
  • Strong project management and communication skills are required. 
  • Experience working with remote global teams
  • Proficient with MS Office required and O365 experience highly desirable.
  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
  • Certificates or other education in clinical research, regulatory compliance or contract/budget management preferred. 

#LI-DNI

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.

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San Rafael

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