Atlanta Center for Medical Research

Scope

Manages site level budgeting and contracting responsibilities for applicable clinical trials.

Ensures clinical trials are carried out consistent with service level agreements. Provides oversight and directives to ensure legal and regulatory standards are adhered to.

Work closely with internal stakeholders and external parties to manage any study related challenges.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life, and 401k.

Job Location: Salt Lake City UT, Gaithersburg MD, or may consider US-Remote.

Duties

Responsibilities:

  • Facilitate study contract and budget negotiation with Sponsors, CROs, and vendors as needed
  • Manage a team of 5-7 employees located in five U.S locations.
  • Comply with current protocols, SOP’s, GCP’s, IRB, and FDA guidelines
  • Create, negotiate, submit, and modify study budgets
  • Submit study financial contracts
  • Ensure all parties comply with study financial contracts and applicable company policies
  • Maintain communication with sponsor through execution of agreements and coordinate budget details with other departments as appropriate
  • Communicates legal / budgetary issues to internal stakeholders and external parties.
  • Responsible for preparing budgets for new studies and evaluating financial viability of all studies
  • Review agreements language to determine changes required based on company requirements
  • Prepare costs estimates for Business Development for opportunities / RFPs
  • Provide support and recommendations as needed with study feasibility and pre-study selection process
  • Facilitate budget / contract amendments
  • Submit CDA/NDA agreements in a timely manner

Qualifications

Education/Experience/Skills:

  • Bachelor’s Degree or equivalent required, degree in Finance preferred
  • Previous management experience
  • Prior experience in Phase 1 contracting preferred
  • Previous experience within one or more of the following therapeutic areas; Psych, Vaccine, Asian Bridging, and Pain
  • Prior experience working with clinical contracts
  • Read, write, and speak fluent English
  • Excellent verbal and written communication skills
  • Strong collaboration skills required. Must be able to work effectively with teams both internally and remotely.

CenExel Clinical Research is an Equal Opportunity Employer.  All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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