Clinical Trial Manager - FSP

When our values align, there's no limit to what we can achieve.   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Overview ​​The Clinical Trials Manager (CTM) will be a member of client’s Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.​​  Key Accountabilities:   Oversight of activities   - Manage external vendors and contract research organizations   - Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual   - Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents   - Assist with protocol development and study report completion   - Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols   - Provide guidance, direction, and management to CRAs   - Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities   - Coordinate study supplies   - Negotiate contracts with vendors of clinical trial services   - Review Informed Consent Forms, CRFs, and study related materials   - Plan and participate in investigator meetings   - Assist and support data query process   - Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines   - Ensures trial master file is current and maintained     Collaborative relationships   - Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.     Compliance with Parexel standards   - Complies with required training curriculum    - Completes timesheets accurately as required    - Submits expense reports as required    - Updates CV as required    - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements       Skills:   - Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.   - Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.   - Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment   - Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders      Knowledge and Experience:    - Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)   - Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)   - Experience of data management and query resolution in clinical trials   - Overall knowledge of site management and monitoring procedures      Education:   - Degree in the life sciences field preferred