Job Details
Responsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I IV of development.
RESPONSIBILITIES
- Clinical Operations team member: works closely with the Sr. CTM and/or Director of Clinical Operations and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables
- Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders
- Interact with clinical research investigators, Key Opinion Leaders and sites.
- Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects
- Accountable for clinical operations updates to team, ensuring (timelines are met and within budget) and in compliance with SOPs, regulations and ICH/GCP guidelines.
- May provide technical advice to team members.
- Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
- Interact with Senior Management to report on progress of milestones.
- Facilitation of quality assurance and processes for assigned project(s)
- Responsible for study drug distribution and accountability processes and documentation
- Oversight of study start-up, study management, data cleaning, and study closeout activities
- Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
- Participates in SOP development, study protocols, study plans process mapping, training of junior CTMs and CTAs, and other departmental activities
- Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents
- Leads and participates in internal cross functional clinical team meetings; serves as main point of contact for study level status updates
- Presents at clinical team meetings and other forums on study progress
- Works with Study Start up and coordinates study start up activities including feasibility, investigational product and materials preparation, trial master file set up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments
- Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors
- Direct line management and supervision of CTAs.
QUALIFICATIONS
- Science background, BS or healthcare degree required, Masters preferred
- Experience: 5+ years clinical research experience in a pharmaceutical/biotech setting
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong leadership, interpersonal, organizational, and multi tasking skills
- Excellent attention to detail and problem solving skills
- Must be able to work in Fast paced environment
- Ability to work effectively in a team setting
- Must be in the Waltham office 2 days a week (flexible hours)