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ModeX Therapeutics Inc · 2 months ago

Clinical Trial Manager (CTM)

Weston, MA

Full-time

Onsite

Mid, Senior Level

4+ years exp

ModeX Therapeutics Inc is seeking a Clinical Trial Manager (CTM) to join their clinical operations team. The primary role involves ensuring that all trial deliverables are met according to timelines, budget, and quality standards, while overseeing the implementation and management of clinical studies.

BiotechnologyManufacturing

Responsibilities

Oversight of the successful implementation, management, and closeout of ModeX clinical studies

Support the clinical protocol development process in collaboration with the Head of Clinical Operations and the Medical Monitor

Contribute in the development of clinical protocols, amendments, and related documents; drive and/or contribute to the development of trial-related documents and processes

Assist in the management of 3rd party vendors with primary focus on the CRO

Lead the development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities

Develop relationships with Investigators and Site Staff as primary contact for clinical conduct of the trial

Under the guidance of the Head of Clinical Operations, manage 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 site identification; attending PSVs and SIVs

Oversee 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 internal teams, sites, central reference labs, specialty lab partners, external collaborators (e.g. Academia) and third-party vendors

Oversee management of accurate enrollment log/trial allocations forms

Ensure compliance with patient consent for collection and intended use, destruction, storage and/or future, post-study use of biological samples

Communicate with management to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status

Participate in process improvement projects (as necessary)

Qualification

Clinical trial executionClinical drug developmentMicrosoft OfficeElectronic data systemsRecord keepingTeamworkCommunication skillsOrganizational skillsInterpersonal skillsSelf-motivatedProject management

Required

BA/BS degree required

The successful candidate should have a minimum of 4+ years of experience in clinical drug development or clinical trial execution with exposure to biomarkers or immunogenicity sample activities including sample collection procedures and logistics considerations

Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems

Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues

Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills

Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously