Specialist Clinical Trials

Cambridge, US | full time | Job ID: 9984

Position Summary:

The Specialist, Clinical Trials assists the Manager, Clinical Trials or Associate Director, Clinical Trials in executing clinical trials, with a primary focus on operational and administrative aspects. This includes preparing and processing national and international project documents or processes in compliance with local laws, international guidelines (ICH-GCP), and applicable SOPs. This role also performs project-related activities within the specified timelines under the supervision of the Manager, Clinical Trials.

Responsibilities:

• Coordinate study-related documents such as feasibility questionnaires, Study Management Plans, Monitor Manuals, etc.
• Support the coordination and/or review of clinical trial documents, e.g., synopsis, investigator brochures, patient informed consent documents, etc.
• Assist in the planning and conduct of project training prior to the initiation of project activities; oversee the training matrix and ensure document completion by team members
• Organize, document, and conduct trial team meetings
• Contribute to Trial Master File setup, maintenance, and close-out (paper or electronic) during the clinical trial and perform regular QC checks
• Support the organization and participation in investigator meetings
• Coordinate contract negotiations with trial sites, pharmacies, and local labs
• Assist with internal or site audits and/or inspections within the scope of a project
• Ensure adherence to regulatory requirements, ICH-GCP guidelines, and respective procedures (e.g., policies, SOPs, instructions)
• Enable the Clinical Operations study team to work efficiently and in an organized manner
  
  

Requirements:

• Bachelor’s degree is preferred
• An advanced degree in a related field with a minimum of one (1) years of relevant work experience may be considered
• Experience in clinical trials, including practice in project planning and structuring
• Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for conducting clinical research projects
• Ability to recognize problems and identify solutions collaboratively with the project team
• Demonstrated use of project management skills, including teamwork, analytical and problem-solving abilities, time management, and organizational skills
• Proactive approach to work, with the ability to begin working independently
• Strong proficiency in English (written and spoken)
  
  

Expected Pay Range: $63,300/year to $101,300/year benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance
  
  

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.