[Hiring] Clinical Trial Manager - Phase I (Healthy Volunteers) @Parexel

Role Description

Parexel is currently seeking a Clinical Trial Manager (CTM) to join us in the UK, dedicated to a single sponsor. This role will focus on Phase I Healthy Volunteers trials and will act as a member of the sponsor’s Development Operations team.

The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. Working as a Clinical Trial Manager at Parexel FSP offers tremendous long-term job security and prospects, undertaking vital clinical studies for sponsors including leading global biotechs and Pharma top 50.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Manage external vendors and contract research organisations.
• 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; 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 sponsor’s SOPs and FDA and ICH guidelines.
• Ensure trial master file is current and maintained.

Please note that responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.

Qualifications

• Bachelor’s, nursing degree or equivalent required, science preferred.
• 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO).
• Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device).
• Proven experience of clinical trial management.
• Experience in CNS and/or oncology is preferred.
• Proven management/leadership of people in a matrixed environment.
• Management of global clinical trials.
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Demonstrated ability to work independently and in a team environment.
• Travel required. Must be willing to travel 15-25%, including international travel.
• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
• Excellent oral and written communication skills and strong organisational abilities.

Benefits

• Open and friendly work environment.
• Opportunities to develop long-term careers.
• Chance to tackle further responsibilities or develop skill set within other related departments of Parexel.

Company Description

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

• Supported the trials of most of today’s top 50 best-selling drugs.
• Enable more niche drug developments that are critical to the well-being of many patients.
• You’ll be an influential member of the wider team.