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 Originally posted on Himalayas