Clinical Trial Manager

BioNTech•Berkeley Heights, NJ

About The Position

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.

Requirements

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.

Nice To Haves

Experience in Oncology is preferred

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

Benefits

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