Clinical Trial Manager/Senior 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. The Clinical Trial Manager/Sr. Clinical Trial Manager will be a member of client’s Development Operations team. The CTM/Sr. CTM 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.

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 :   Experience managing global clinical trials in Oncology and/or Neurology 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  #LI-LO1