Sr Clinical Trial Manager Job in United States | Yulys
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Job Title: Sr Clinical Trial Manager

Company Name: SciPro
Salary: USD 150,000.00
-
USD 190,000.00 Yearly
Job Industry: Biotechnology
Job Type: Full time
WorkPlace Type: remote
Location: United States, United States
Required Candidates: 1 Candidates
Skills:
knowledge of biology
maths knowledge
analytical thinking skills
Job Description:

SciPro has been retained by a subsidiary of a VC backed biologics incubator to hire a Senior Manager/Associate Director Clinical Operations.

 

This position will work closely with their CSO and CMO as well as VP of Preclinical Development on their antibody pipeline. The biotech start up has 2 programs (mAb, BsAbs) that includes a Phase Ib rheumatoid arthritis trial.

 

They are seeking someone to oversee and manage clinical trials across early development phases in their autoimmune pipeline. The ideal candidate will have a strong background in study start-up activities and extensive experience in managing Contract Research Organizations (CROs) to ensure efficient and successful trial execution.

 

Responsibilities:

Study Start-Up Management:

  • Lead and oversee all aspects of study start-up activities, including site selection, investigator meetings, protocol development, and regulatory submissions.
  • Ensure timelines are met for site initiation, patient recruitment, and enrollment.
  • Collaborate with cross-functional teams to develop study plans and strategies.

CRO Management:

  • Manage relationships with CROs and other external vendors to ensure adherence to timelines, budgets, and quality standards.
  • Provide oversight and guidance to CROs throughout the trial lifecycle, including contract negotiation, performance management, and issue resolution.
  • Conduct regular meetings and reviews to assess CRO performance and ensure alignment with project goals.

Clinical Operations Oversight:

  • Implement and execute clinical trial protocols, ensuring compliance with ICH/GCP guidelines, SOPs, and regulatory requirements.
  • Monitor trial progress, identify risks, and develop mitigation strategies.
  • Manage clinical trial budgets, forecasting, and resource allocation.

 

This is a role that requires someone to independently manage the CRO. You need to have experience doing this previously at a small biotech company.

 

Qualifications:

  • Bachelors degree in science, advanced degree optional
  • 3-5 years industry experience. Need to have worked at a small biotech previously
  • Proven experience in managing clinical trials from start-up through close-out phases.
  • Extensive experience in managing CROs and other external vendors.
  • Biologics experience is a nice to have
  • Autoimmune experience is preferred

 

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