This CTM will need to independently organize and manage multiple clinical trial activities including facilitating cross-functional team meetings, managing vendors, and addressing protocol related questions. S/he would also be ensuring that study milestones are met and that the trial is completed in accordance with the protocol, study milestones and within budget.
What You’ll Do.
- Responsible for all operational management of clinical trials.? Position serves as lead for a new clinical program
- Selection and management of CRO, vendors and consultants that are involved with the clinical trial
- Oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and the study Oversight Plan, including review of CRO progress reports and metrics
- Coordinate financial and legal documentation exchange between sponsor, vendors and sites
- Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines
- Organize and facilitate/document study cross-functional team meetings
- Serve as point person for trial execution internally & externally
- Coordinate and participate in data reviews in conjunction with Data Management staff
- Review study Trial Master File periodically for quality control measures
- Review and provide input for clinical study documents such as informed consent, protocols, Investigator’s Brochure, recruitment materials, yearly updates to the regulatory authorities and status updates
- Review and approve study related plans generated by CRO and study vendors
- Responsible for oversight of identification and selection of investigator sites
- Responsible for communication and escalation of study related risks and issues as required
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs
- Assist in the oversight of monitoring activities and site visits
- May represent Clinical Operations in cross-functional initiatives
- Participate in review and revision of departmental SOPs, provide support to establish and maintain operational infrastructure
- Manage and attend Investigator Meetings, conferences, and perform co-monitoring as needed.?
What You’ll Bring.
- Knowledge – thorough understanding of GCP/regulatory requirements
- Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
- Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
- Strong communication – able to communicate clearly (in writing and verbally)
- Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
- Leadership – skills to lead and motivate a team for timely study execution
- Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions
You May Also Bring.
- Demonstrated computer skills including functional knowledge of Microsoft packages and ability to develop proficiency in technical systems and programs
- Experience developing, reviewing, and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
- Experience managing CROs, vendors, and/or clinical trial consultants
Preferred Education & Experience.
- B.S. (or equivalent experience) and 3 - 6 years of relevant work experience
- M.S. (or equivalent experience) and 2 - 4 years of relevant work experience