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