Associate Director, Clinical Trial Management

ModeX Therapeutics•Weston, MA

About The Position

The Associate Director, Clinical Trial Manager is a valued position within the ModeX clinical operations team. The primary role of this position is to ensure all trial deliverables are met according to timelines, budget, operational procedures, and quality standards (e.g., GCP, ICH, and ModeX standards). This includes independent responsibilities associated with planning, start-up, maintenance, and closeout of clinical trials, as well as providing leadership and mentorship to study team members. The Associate Director CTM is expected to guide cross-functional collaborators, support the development of junior staff, and foster a high-performing, collaborative team environment.

Requirements

BA/BS degree required
7-10+ years of relevant professional experience, with 5+ years of clinical operations experience in immunology, oncology or rare diseases.
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

Responsibilities

Oversee the successful implementation, management, and closeout of ModeX clinical studies
Understand and track day-to-day budget and major budget milestones
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 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)