CLINICAL TRIAL MANAGER (CTM)

SCOPE

Brand new opportunity to join a growing Clinical Operations team supporting multi-phase clinical trials. With a strong oncology portfolio and excellent financial standing, this company is bringing on industry leaders and now is the time to join them. As a Clinical Trial Manager, you will oversee all aspects of study initiation, implementation and progress and will lead a team of dedicated oncology drug development experts.

RESPONSIBILITIES

• Monitor study progress and provide regular updates to senior management and stakeholders
• Contribute to developing, implementing and updating SOPs, study protocols, laboratory manuals and other study-related documents
• Coordinate and provide site and CRA training to ensure protocols are implemented and followed in accordance with SOPs and industry regulations
• Manage CRO and other study vendors, including developing and revising service agreements, budgets and timelines and reviewing and approving expenses
• Develop monitoring plans and guidelines and co-monitor visits as needed
• Ensure clinical sites have all necessary supplies and documentation
• Perform regular reviews and quality check data and documents uploaded to the trial master file
• Identify, report and resolve issues within clinical operations study team

EDUCATION/EXPERIENCE

• Bachelors degree in life sciences or equivalent required
• Advanced degree in life sciences preferred
• 3+ years clinical trial management experience required
• Previous oncology clinical trial experience strongly preferred
• Demonstrated knowledge of industry regulatory requirements, including ICH/GCP and clinical trial operations guidelines

SKILLS:

• Excellent verbal and written communication skills
• Strong management skills and demonstrated team-building skills
• Ability to work in fast-paced environments within strict timelines

My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or e.mato@hamlynwilliams.com.