Clinical Trial Manager FSP

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Job Overview

The Clinical Trials Manager (CTM) will be a member of clients 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 clients 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