Manager, Clinical Project

BioMarin Pharmaceutical Inc.

At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

 

Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

 

BioMarin is pleased to offer a comprehensive benefits program that extends beyond that commonly seen in the biotech industry. Currently, there are no out of pocket costs for eligible employees and their eligible dependents.

 

EEO/M/F/D/V

To apply: Visit www.BMRN.com Job Code 08-0103

SUMMARY DESCRIPTION

This position is responsible for the implementation of one or more clinical studies (phase I through phase IV), possibly across therapeutic areas.

RESPONSIBILITIES

• Management of the overall conduct and operational activities of one or more clinical studies within a project.
• Distribution and delegation of clinical project work.
• Identification, selection and management of CROs and other vendors as needed.
• Mentoring of less experienced Clinical Operations staff.
• Management of internal project related clinical staff including record keeping for use in supervision.
• Assists with (or lead, when necessary) the development of clinical documents such as protocols, investigator brochures, study reports, and annual reports.
• Contribute to project clinical team meetings and core team meetings to provide operational update, plans, and recommendations.
• Contribute to the development and review of clinical SOPs.
• Participate in interviewing, selecting and training clinical staff.
• Review data management plans.
• Ensure the management of clinical supplies.
• Creation of clinical study metrics and other management-reporting tools.
• Development and maintenance of clinical study timeline.
• Ensure compliance with protocol, regulatory and overall clinical objectives.
• Development and management of clinical budgets as needed.
• Development of contingency plans for clinical studies as needed.
• Other duties as assigned.

EDUCATION

BS/BA in a scientific or medically related field, RN preferred.

EXPERIENCE

• Excellent oral, written and interpersonal skills.
• Ability to manage the clinical operations of multiple studies.
• Broad and deep knowledge of clinical trial documentation, including monitoring requirements, FDA regulations, and operational aspects of clinical trials.
• Timeline and budget development and management experience.
• Personnel management experience preferred.
• Excellent organizational skills.
• Attention to detail.
• Proficiency in software applications such as MS Word, Excel, etc.
• 8+ years experience in Clinical Affairs/Clinical Operations for a biotechnology or pharmaceutical company.
• International clinical study experience and previous BLA/NDN experience helpful.

EQUIPMENT

Computer work, utilizing common software programs.

CONTACTS

Internal:  Clinical Project Team, Core Team personnel, Safety Associate, other Clinical Operations staff.
External:  CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies.

SUPERVISOR RESPONSIBILITY

Clinical Operations personnel who may directly or indirectly report to this position include Sr. CRAs, CRA IIs, CRA Is, CR Assistants, Clinical Document Management (CDM) Specialist, and Clinical Document Management (CDM) Coordinator.

To apply: Visit www.BMRN.com Job Code 08-0103