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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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 Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. 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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