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BioNTech SE · 21 hours ago

Clinical Trial Manager

Berkeley Heights, NJ

Full-time

Onsite

Mid, Senior Level

$123K/yr - $182K/yr

5+ years exp

BioNTech SE is a leading biopharmaceutical company focused on developing innovative therapies and diagnostics. They are seeking a Clinical Trial Manager responsible for executing clinical trials, ensuring compliance with regulations, and managing cross-functional teams to support the development of clinical protocols and trial-related documents.

Health Care

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

Qualification

Clinical Study ManagementICH-GCP KnowledgeRegulatory Inspections ExperienceOncology ExperienceProject Management SkillsAnalytical SkillsRisk ManagementCost ManagementPerformance MonitoringTeamworkProblem-SolvingTime ManagementOrganizational Skills

Required

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

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

Preferred

Global Phase I-III experience required or experience with biomarkers and/or immunogenicity sample activities including sample collection procedures and logistics considerations preferred

Experience in Oncology is preferred