Manager, Clinical Operations

Rhode Island Bar Assn.; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading company in the clinical operations sector seeks a skilled project manager to supervise clinical studies and support groundbreaking cancer immunotherapy efforts. Responsibilities include managing study execution, ensuring quality standards, and vendor oversight. Applicants should have a relevant degree and significant experience in project management or clinical trials.

Qualifications

• Minimum of 3 years experience in project management or clinical trial coordination.
• Profound knowledge of ICH-GCP guidelines.
• Background in natural/life sciences or medical profession.

Responsibilities

• Lead cross-functional teams for clinical study execution.
• Define and implement study quality standards.
• Oversee vendors and ensure adherence to timelines.

Skills

Project Management

Regulatory Submissions

Clinical Trials Monitoring

Problem Recognition and Solution

Organizational Skills

Communication Skills

Proactive Work Style

Education

University degree in natural/life sciences or medicine

Tools

Word

Excel

Power Point

MS Projects

Job description

As a part of our Global Clinical Operations Team, you will soon take the next step with us. Together with your colleagues, you will supervise clinical studies and support BioNTech become a worldwide forerunner for modern immunotherapies against cancer.

Your Main Responsibilities Are:

• Lead a cross functional team for study execution for one or several studies
• Responsible for defining and implementing the study quality standards and study objectives as agreed with the program team
• Preparation and review of study documents with CROs as well as the selection of vendors for the study
• Responsible for Vendor oversight and issue resolution/escalation for the responsible studies
• Responsible for ensuring study timelines are per plan or mitigations are introduced to limit timeline shifts
• Work with cross functional team and the CRO to prepare and compile documents for ethics committee and health authority submission
• Plan, review, and conduct of training sessions relevant to the studies as well as team and investigator meetings/PSVs/SIVs

What You Have To Offer:

• Background in natural/life sciences or medicine (University degree or experience in a medical profession such as Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant) with a minimum of 3 years of experience in project management, regulatory submissions, monitoring of clinical trials, or clinical trial coordination
• Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
• Experience in usual software (Word, Excel, Power Point, MS Projects)
• Able to recognize problems and provide solutions
• Good organizational and communicative skills
• Pro-active way of working & ready to take over responsibility