Job Description

The Clinical Trial Manager (CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The CTM participates in cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines.

Primary Duties and Responsibilities:

Manages clinical trials and data collection
Establishes scientific methods for design and implementation of clinical protocols, data collection systems and final reports
Monitors adherence to protocols and determines study completion
Monitor study sites and activities to ensure the protocol and terms of the study are being followed
Identifying, managing and collaborating with contract research organizations (CROs) and other study personnel
Identifying, evaluating and establishing trial sites and closing sites down upon completion of trial
Tracking and following up on enrollment, discontinuation and completion of study subjects
Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner
Obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, R&D, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
Provides input on the development of CRF design
Liaising with regulatory authorities when applicable
Participates in data cleaning, listing, and report output reviews
Develops, reviews, and approves study-related manuals, plans, specifications, instructions for use, charters, newsletters, and materials
Participates in protocol deviation listing reviews and meetings
Responsible for oversight of site study budget, investigator and vendor contracts, budgets and payments
Participates in the protocol, table, figure, data listings, and clinical study report reviews
Develops presentations for clinical sites, team and investigator meetings
Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready
May be responsible for a defined region, vendor or process across a program

Education/Experience/Skills:

Bachelor’s Degree in a life science plus the knowledge and skills typically acquired through a minimum of 3-5 years’ relevant industry experience in medical research, nursing or pharmaceuticals/devices.
Minimum 2 years experience on the Sponsor side
Experience with data entry, EDC systems, regulatory review and submissions
Experience with diagnostics, LDT's preferred
Previous clinical work experience that provides the knowledge, skills, and abilities to perform the job
Experience utilizing CTMS, EDC, TMS and related software
Prior experience in management and monitoring of CRO and investigative sites, preferred
Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay
Excellent written and verbal communication skills
Ability to multi-task and re prioritize workflow as necessary
Proficient knowledge of Microsoft Office Suite and the ability to learn additional necessary software

Valid through: 2/16/2021