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Senior Trial Specialist, Study Budgets and Contracts, Study Management (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.

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. 

Duties


SUMMARY DESCRIPTION



The Senior Trial Specialist role, study budgeting and contracting, within Global Medical Affairs (GMAF) Study Management (SM) is an independent, experienced role responsible for the vendor relationships, budgeting and contracting aspects for all study(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.



KEY RESPONSIBILITIES



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 Director and Study Managers

    • Collaborate with the Program Director and Study Managers 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

Skills


COMPETENCIES


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


Education



    • 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

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


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.

About our location

San Rafael

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