Clinical Operations Manager

Location
Boca Raton, FL
Posted
Sep 10, 2020
Ref
23099
Required Education
Bachelors Degree
Position Type
Full time
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.

Independently manages multiple clinical trials of moderate complexity. The COM is expected to manage all sites and vendor (e.g. Clinical Research Organization) related issues, with supervision from the Senior Manager, Clinical Operations.

Essentials of the Job:
  • Manages study operational plan and CRO activities, including project timelines & quality of deliverables , and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
  • Participates in the selection, contracting, budget, invoicing, and payment of study vendors and investigational sites for assigned studies
  • Maintains frequent contact with CROs and other study vendors to assess performance and provide guidance as needed
  • Contributes to relevant study documents including clinical protocols, CRFs, clinical study reports and operational plans (CMP, DMP, SMP, etc.)
  • Proactively identifies project risks and provides solutions
  • Oversees clinical trials sites' adherence to pertinent regulations through review of monitoring reports, audit reports, communications with investigators, study site personnel, CRAs and other CRO personnel
  • Provide or facilitate training to clinical study teams on protocols and/or specific topics
  • Oversees the submission of trial-related and essential documents to the Trial Master File
  • Work closely with other internal teams (e.g. QA, PV, Regulatory, etc.)
  • Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested




Education Requirements: Bachelor's Degree in the Biological, Biomedical, or Life Sciences.

Experience Requirements: Minimum of 5 years of clinical research experience, at least 2 of which are as a clinical project manager at a pharmaceutical company or CRO; some monitoring experience preferred; previous experience negotiating vendor/site contracts and budgets preferred

Other Essential Knowledge : Thorough knowledge of clinical trial process/design and GCP, ICH, and DFA regulations. Detailed understanding of all aspects of clinical protocol design and implementation and overall drug development. Excellent written and verbal communication skills. Strong interpersonal communication skills. Great attention to detail and strong planning/organizational skills. Solid knowledge of Microsoft Office Products. Willingness to travel within the U.S..

In addition to competitive compensation, we offer a comprehensive benefits package including:
  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • 3 Weeks' Paid Time Off (within the first year) / Company Paid Holidays and Personal Days
  • Tuition Assistance (after the first year
  • Easily accessible to Tri-Rail / Company paid shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.