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 manage multiple, high-priority tasks simultaneously.
- Ability to utilize resources efficiently.
- Ability to lead by example, inspire teamwork, and motivate staff.
- Excellent organizational, communication, and planning skills.
- Ability to work independently.
- Ability to contribute to the development of SOPs, tools and processes as needed for corporate growth and performance.
- Fluent in English with excellent communication skills (both written and verbal).
EDUCATION and/or EXPERIENCE:
The above qualifications may be gained through completion of a Bachelor’s Degree (preferably in health science) with a Masters or other advanced degree preferred. Applicant must also have a minimum of five years of experience in the clinical pharmaceutical industry, including demonstrated competency in clinical project management tasks.
TRAVEL REQUIREMENTS:
- Must be available for domestic/international travel including overnight stays.
- Must have the ability to safely operate an automobile and a valid driver’s license.
