Oncology Project Manager

Now hiring for positions in our U.S. clinical operations headquarters in Nashville, Tennessee

Medelis is a full service oncology Clinical Research Company. We provide sponsors with a highly-skilled and proactive oncology clinical trial management team to design and manage phase I through phase III oncology trials in North America and Europe.

We are looking for an experienced Project Manager to work in a fast paced oncology research environment. Successful applicants must be organized, motivated, a quick learner with good communication skills.

Responsibilities For Project Manager

• Provide daily management and oversight of assigned clinical research studies and programs, promoting teamwork and resolving conflicts as needed.
• Ensure proper conduct of ongoing clinical research studies in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and /or client SOP’s, and professional standards.
• Contribute to development and evaluation of department’s SOPs and processes as needed.
• Continuously evaluate assigned projects for areas where improvements can be made and implement efficiencies to improve the quality of work delivered to the client.
• Establish good working relationships with client project teams to ensure client satisfaction.
• Ensure efficient identification and successful selection of investigational research sites for participation in clinical research trials (if applicable).
• Prepare/review investigator clinical trial agreements and negotiate study budgets as required.
• Develop, implement, and revise study-specific project plans (e.g., quality plan, monitoring plan, communication plan, safety management plan, etc.) and other study-related guidance documents to ensure efficient workflow.
• Assist with the development of case report forms, monitoring tools, and necessary study guides for project teams and investigational research sites (as applicable).
• Develop and implement study/program timelines in conjunction with internal team and client.
• Develop and maintain project tracking spreadsheets to ensure current monitoring of study/program progress.
• Define project/program resource needs and manage resources effectively.
• Communicate with clients regarding project status and study-related issues. Act as primary client liaison as needed.
• Coordinate and manage all contracted tasks (e.g. clinical monitoring, data management, regulatory affairs, serious adverse event reporting, final study reports, etc.) associated with assigned clinical studies.
• Manage the Regulatory Affairs function for assigned studies and assume primary responsibility for regulatory reporting timelines.
• Manage study budget and scope of work for assigned projects/programs.
• Coordinate activities of vendors as required.
• Coordinate and participate in Investigator Meetings as required.
• Participate in required project-specific teleconferences or face-to-face meetings.
• Lead or participate in protocol-specific training and other developmental activities.
• Participate in client audits or regulatory authority inspections and work with Quality Management to provide responses to audit/inspection findings.
• Ensure implementation of corrective/preventive actions that are identified in Quality audits or regulatory inspections.
• Prepare proposal materials and participate in presentations to clients; assist with other business development activities.
• Evaluate staff training needs and assist in the training and development of staff; mentor staff as needed.
• Participate in employee recruitment and performance based assessments.

Requirements For Project Manager To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Thorough knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines. Global project management experience recommended.
• Excellent computer skills with various software programs including Microsoft Word, Excel and Outlook.
• Skilled in financial control procedures for assigned studies.
• Ability to develop time and cost estimates for potential and ongoing projects/programs.
• Ability to work with investigative sites and Medelis clients by proactively assessing their needs, negotiating effectively, and liaising in a professional manner.
• Ability to m…