Sr. Trial Specialist, Study Management Budgeting and Contracting, Global Medical AffairsLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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. Trial Specialist role, budgeting and contracting, within Global Medical Affairs (GMAF) Study Management & Data Analytics (SMDA) is an independent, experienced role responsible for the vendor relationships, budgeting and contracting aspects for all trial(s) under a specified program. Responsibilities will focus primarily on relationships with vendors, program and site level budgets and contracting.
The individual in this role exhibits foundational level skills related to communication, leadership, strategic thinking, adaptability, flexibility, drug development, and therapeutic area knowledge. S/he has advanced technical skills related to compliance.
Responsibilities may include, but are not limited to:
Contracts and Vendor Management
- Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Managers, Legal, and Finance
- Create, maintain and review study forecast tool and template site budgets for each study in collaboration with the Program Manager/Director and Study Managers
- Collaborate with the Program Manager/Director to review fair market value assessments for steering committee members and site budget templates
- Participate in the selection of vendors and oversight of vendors across assigned program
- Support the management of vendors across assigned program, including contract negotiations, change orders, budgeting and accruals, in collaboration with the Study Managers
People Management and Development
- Train, mentor and support junior staff supporting assigned trials, if assigned
The Senior Trial Specialist demonstrates foundational leadership, communication, and adaptability. For example:
- Demonstrating willingness and flexibility to achieve a common goal when change occurs
- Taking ownership of, and accountability for, the completion of assigned tasks, while demonstrating professional maturity
- An ability to facilitate small (e.g., activity or country specific) meetings, including developing the agenda and completing follow-up, with oversight
The individual in this position is expected to demonstrate advanced competence in compliance, along with foundational competence in drug development and therapeutic area knowledge. This includes (but is not limited to):
- Being adept at recognizing a breach in GCP/GVP and ability to mitigate compliance risks for a clinical trial
- Understanding the objectives/purpose of each drug development phase
- Demonstrating basic knowledge of relevant therapeutic areas and disease conditions, particularly in rare diseases
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GMAF has been defined and is available to employees of BioMarin.
EDUCATION AND EXPERIENCE
- BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
- 4 years of relevant experience in clinical science, clinical trial or site management, medical affairs, site and/or program level budgeting or contracting, and/or drug development
- Some experience mentoring junior staff is preferred
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.