Surgical Manager

Parexel is currently seeking a Senior Clinical Trial Manager (SCTM) to join us in the UK, dedicated to a single sponsor. This role 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 Senior Clinical Trial Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
• Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials.
• Provide direction and leadership in CRO and vendor selection and management.
• Knowledge of regulatory start up process and planning in support of study start up.
• Managing and maintaining high performing clinical teams.
• Coordination of global clinical trials.
• Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
• Be responsible for and manage clinical research activity of Clinical Operations team.
• Estimate, track and critically analyze vendor financial spend on study.
• Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs.
• Provide guidance, direction, and management to site monitoring activity.
• Coordinate patient enrollment activities and mitigation planning.
• Coordinate study supplies with regulatory and clinical supplies functions.
• 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 Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines.
• Ensures 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.

Here are a few requirements specific to this advertised role.

• 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.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who Are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we 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.