Clinical Project Manager

**Clinical Project Manager**

**Job Purpose/Summary**

**What You’ll Do**
- Plan, implement, evaluate, and complete full execution of assigned clinical trials; may function as a global trial lead
- Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within 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 including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; manage multiple projects simultaneously
- 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 client contact at project operational level
- Provide oversight to contracted vendors; review contracted specifications and maintains 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; provides 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 an as-needed basis to provide support to CTI and/or site staff
- Implement project activities according to scope of contracted work
- Evaluate and manage project budget against project milestones and scope; 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 and works 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; ensures 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
- Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)
- Suggest and participate in process improvement activities and initiatives

**What You Bring**
- Excellent verbal and written communication skills
- Ability to foster strong customer service and collegial relationships with clients, peers and other internal and external customers; demonstrates effective interpersonal skills to provide positive leadership
- Ability to manage assigned CPM responsibilities
- Excellent organizational, record retention and time management skills
- Excellent decision-making and creative problem-solving skills
- Demonstrated critical thinking skills and ability to effectively manage shifting priorities
- Demonstrated strong knowledge and clear understanding of CTI SOPs
- Demonstrated ability to effectively manage conflict and facilitate problem solving by offering solutions
- Demonstrated accountability and follow through on all assigned projects
- Proficient use of computer and software systems
- Ability to understand, interpret, and explain medical details associated with assigned trials
- Ability to acquire and synthesize new knowledge and assimilate this with current practic