Clinical Project Manager

**Clinical Project Manager**
**(Level Depends on Experience)**
**Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or advanced Clinical Project Management (CPM) staff in the management of the essential functions of the CPM role listed below.
**What You’ll Do**
- Plan, implement, evaluate, and complete full execution of assigned clinical trials; with support of assigned trial Director
- Set goals and timelines, provide oversight and fosters motivation within the team to accomplish goals within the defined timelines and with high quality in the execution of assigned clinical trials
- Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
- Provide management of full scope clinical trial projects from start-up through analysis phase including oversight of functionally assigned team members on clinical trials projects; may be assigned to multiple projects simultaneously
- Implement project activities according to scope of contracted work
- Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities
- Prepare or provide oversight to the development of trial plans and timelines; work with the trial-assigned Director or line manager to provide effective solutions to challenges that arise during the clinical trial project
- Participate in or provide oversight and guidance in the development of trial required deliverables
- Serve as a client contact at project operational level
- Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations
- Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management
- Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues
- Ensure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol
- Provide day-to-day oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA’s management of sites and monitoring of the clinical trial data. Review and approve site trip reports and escalates site issues as needed to assigned trial Director, CTI executive management and/or client/sponsor in accordance with the trial’s Communication Plan
- Attend site visits on as needed basis for observational purposes or to provide support to CTI and/or site staff
- Evaluate and manage project budget against project milestones under the supervision of the trial-assigned Director; work with the trial-assigned Director to take corrective measures where necessary to keep project in line with budget
- Assess scope of work against client contractual agreements under the supervision of the trial-assigned Director and work with trial-assigned Director to facilitate change of scope orders when appropriate
- Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes
- Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects
- Participate and provide oversight in the planning of Investigator meetings; develop meeting agendas or related materials and conduct presentations
- Provide oversight in the management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial’s TMF Plan
- May participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)
**What You Bring**
- Bachelor’s degree or equivalent, preferably in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience
- 3 years research experience (CRO, CRA, Clinical Site Coordinator, Clinical Research Laboratory) or transferrable skills and experience
**Why CTI?**
- We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
- We value education and training - We provide tuition reimbu

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