Clinical Trial Manager

Title: Clinical Trial Manager

Duties:

  • Must meet all requirements for Senior CTMA position and have demonstrated proficiency in all relevant areas.
  • Coordinating and supervising all aspects of a clinical study.
  • Monitors clinical trial sites.
  • Assists Clinical Program Manager in overall study management.
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
  • Maintains study timelines.
  • Contributes to development of study budget.
  • Contributes to development of RFPs and participate in selection of CROs/vendors.
  • Manage CROs/vendors.
  • Coordinates review of data listings and preparation of interim/final clinical study reports.
  • May contribute to development of abstracts, presentations, and manuscripts, Ensures effectiveness of site budget/contract process.
  • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
  • Assists in determining the activities to support a project’s priorities within functional area.
  • Under supervision, may design scientific communications within the company.
  • Travel is required.
  • Excellent teamwork, communication, decision-making and organizational skills are required.
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
  • Must be able to generally understand, interpret, and explain protocol requirements to others.
  • Must be able to prioritize multiple tasks.
  • May serve as a resource for others within the company for clinical trials management expertise.
  • Under general supervision, is able to examine functional issues from an organizational perspective.
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
  • Must have a general, functional expertise to support SOP development and implementation.

 

Experience:

- CTM experience (at least 2 y experience, already performing at the CTM level) – we need experienced people that can hit the ground running immediately

 

- Biotech/ pharma experience required (eventually only CRO experience will be considered if it was in a full-service provider capacity)

 

- Global phase 3 experience required

 

- Inflammation experience preferable

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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