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Clinical Trial Specialist, Clinical Operations

Location San Rafael, California

JOB DESCRIPTION

Job Title:

Clinical Trial Specialist

Department / Cost Center:

Clinical Operations

Reports to (Job Title):

Job Code:

Location:

San Rafael

Date Prepared:

Full-Time     Part-Time

Regular     Temporary

Exempt     Non-Exempt

OVERVIEW:

BioMarin 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’s Development Sciences Operations (DSO) group is responsible for everything from research and discovery to post-market clinical development. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. 

BioMarin’s Clinical Operations group ensures proper planning, conduct, monitoring and data quality from study start-up to close-out. The group is responsible for fostering effective communication and collaboration between study sites and BioMarin.

SUMMARY DESCRIPTION

The Clinical Trial Specialist performs essential responsibilities for successful trial execution at BioMarin. The Clinical Trial Specialist takes on the key role of Study Specialist, contributing to tasks related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL). This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.

KEY RESPONSIBILITIES:

The Clinical Trial Specialist can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:

Quality:

  • Ensure TMF filing and maintenance is done routinely by Clinical Trial Assistant (CTA)

Timelines:

  • Contribute to the development of vendor specific timelines ensuring alignment with study level timelines

Contracts & Budgets:

  • Review and approve invoices for assigned vendors
  • Review investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDev

Clinical Operations Managed Vendors & CRO:

  • May participate in vendor selection
  • Escalate vendor performance and quality issues to the SOL

Protocol & Informed Consent Form(ICF) Development Process:

  • Create and maintain tracker for future amendment changes
  • Actively contribute to the review of any changes to the ICF Master
  • Ensure alignment of country/site specific ICFs with ICF Master

Study Start Up:

  • Manage activities related to Startup as delegated by the SOL
  • Develop study specific documentation as delegated by the SOL
  • Confirm that all site level documents have been collected to support site initiation
  • Contribute to the IP release process
  • Ensure timely study entry and updates to ClinicalTrials.gov

Study Conduct And Close-out:

  • Provide vendor status updates to the Study Operations Lead
  • Identifyand escalate issues relating to study delivery, timelines and site budget to Study Operations Lead
  • Support study close-out activities (sites, reconciliation activities, filing & archiving)
  • Participate in data listing reviews
  • Facilitate timely delivery of clinical documents for the CSRand appendices

Insurance:

  • Ensure an insurance policy is in place for the country and, if applicable, the individual clinical trial sites associated with the protocol and protocol amendments
  • Ensure the required information/documents needed to obtain insurance are made available to CTA
  • Oversee extensions of expiring policies and processing of certificates, as appropriate

Drug or Investigational Product (IP):

  • Support SOL to ensure timely delivery of IP to the sites in collaboration with Clinical Supply Chain (CSC) representative
  • Ensure that CRO/sites are clear on how IP is to be handled according to pharmacy manual

Clinical Governance / Team Membership and Leadership:

  • Attend internal Clinical Operations team meetings, attend vendor meetings as appropriate, based on assignments from SOL
  • Ad hoc attendance at SET Meetings

COMPETENCIES

TheClinical Trial Specialistis expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations acrossCommunication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:

  • Responds promptly with clear, organized written and oral communication
  • Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers
  • Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
  • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly

The Clinical Trial Specialist is also in the process of developing foundationaltechnical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Clinical Operations has been defined and is available to employees of BioMarin.

PEOPLE MANAGEMENT

No people management responsibilities

EDUCATION AND EXPERIENCE

BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.

2+ years pharmaceutical industry experience

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

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 20 lbs. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Some travel may be required.

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions.

CONTACTS

Internal: Clinical Operations team and Study Execution Team Members, Core Team personnel, GCP Compliance, other Clinical Operations personnel; Other BioMarin Worldwide Research and Development functional area personnel; BioMarin Senior Management

External:CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies, clinical sites

About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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