Manager, Clinical Operations

U.S. Bankruptcy Court - District of CT; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

The U.S. Bankruptcy Court - District of CT is seeking a Clinical Operations Team Leader. This role involves supervising clinical studies and ensuring compliance with quality standards. Candidates should have a relevant degree, profound knowledge of clinical research regulations, and experience in leadership roles. Excellent organizational and communication skills are essential for this position.

Qualifications

• Minimum 3 years of experience in project management, regulatory submissions, clinical trial coordination.
• Experienced in ICH-GCP guidelines.
• Background in medical profession such as Nurse, Medical Technical Assistant.

Responsibilities

• Lead a cross-functional team for study execution.
• Responsible for vendor oversight and issue resolution.
• Prepare and review study documents with CROs.

Skills

Organizational skills

Communicative skills

Problem-solving

Proactive approach

Education

University degree in natural/life sciences or medicine

Tools

Microsoft Word

Microsoft Excel

Microsoft 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