The Clinical Trial Manager II w orks in compliance with principles of Good Clinical Practice and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Serve as the clinical point person managing protocol execution. Managing majority open to enrollment (registries, non-treatment, roll over, phase I-IV) and limited number of closed to enrollment studies. Demonstrate proficient performance of study start up activities and development of start-up tools. Lead development of overall clinical strategic operations plan for assigned projects including timelines, internal and external costs, CRO/Vendor Oversight Plans, key deliverables and risk/mitigation strategy. Communicate effectively and work cross-functionally with internal and external teams (site staff, vendors, etc.). Mentor Clinical Trial Manager I.
Partner closely with sites, CROs and pharmaceutical sponsor, including sponsor oversight of relevant functional activities. Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
Ensure all trial deliverables are met according to timeline, budget, and resource requirements. Identify, address, escalate and communicate quality and compliance concerns.
Participate in the development, review and implementation of departmental SOPs and processes. Provide study-specific direction and mentoring to other staff as appropriate.
Minimum Job Qualifications
Bachelor's degree in clinical or scientific discipline (or equivalent experience)
Required: Minimum of four years of clinical research experience (5 years preferred)
Required: Two years of experience in study management/project management of complex studies
Preferred: Prior oncology research experience; multiple phases
Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player. Excellent verbal and written communication skills.
Experience in establishing study operational plans and strategy. Requires a balance of scientific and operational/project management and team leadership expertise.
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
Works in compliance with principles of Good Clinical Practice and applicable federal, state, and local regulations.
Preferred: Prior oncology research experience
Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and
Excellent organizational and priority management skills.
Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
Ability to work within established timelines, in a fast-paced environment.
General Office, may require travel by air or automobile approximately up to 10% of the time.
Large percent of time performing computer-based work is required.
McKesson is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Internal Number: JR0042015
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.