Clinical Trial Manager

New Jersey, US; Cambridge, US; Gaithersburg, US   |   full time   |   Job ID: 9983 

 

 

The Clinical Trial Manager (CTM) is responsible for the execution of 1 or more smaller scale or less complex trials in early or late stage development. They are also the Subject Matter Expert with regard to operational  aspects. This implies preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.

 

Responsibilities:

 

• Perform activities such as leading the cross-functional operational study team lead, independent oversight of third-party providers, ensuring the study is on time with good quality. 
• Facilitates study and related meetings.  Schedules and coordinates meetings, prepares and reviews agendas, presentation materials and minutes for study team meetings or other meetings as delegated
• Support the global clinical protocol development process in collaboration with Clinical Operations Management and the Medical Monitor: Contribute in the development of global clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processes
• Lead the global development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities
• Develop relationships with global Investigators and Site Staff as primary contact for clinical conduct of the trial
• Under the guidance of Clinical Operations Management, manage global study start-up activities including regulatory documents, budget, and clinical trial agreements
• Participate in the ongoing review and cleaning of the clinical trial data
• Chair study team meetings, collecting input from all functional lines
• Participate in global site identification, attending PSVs and SIVs as necessary
• Assist in the management of 3rd party vendors, including CRO, central lab and imaging vendors
• Manage global tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis ensuring that sample inventories are accurate, complete, and up to date through effective interactions with global internal teams, sites, central reference labs, specialty lab partners, external collaborators (e.g. Academia) and third-party vendors

 

Qualifications:

 

• A Bachelor’s degree in the life sciences with a minimum of 5 years of experience in pharmaceutical/biotech or related industry
• Minimum 5 years of professional experience as a Clinical Study Manager, CRA/Clinical Monitor or in a similar function, with at least 3 years managing or involved in a cross functional team for study execution
• Knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
• Experience with regulatory inspections or internal process audits.
• Exposure to responses to Health Authority and Ethics committee questions
• Global Phase I-III experience required or experience with biomarkers and/or immunogenicity sample activities including sample collection procedures and logistics considerations preferred
• Ability to apply some Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring.
• Experience in Oncology is preferred

 

 

Expected Pay Range: $122,600/year to $182,400/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) av