Clinical Trial Manager - Phase I (Healthy Volunteers) - UK (remote) - 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. 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. 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 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 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; 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 sponsor’s 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. Not quite the role for you? Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events. Sign up today https://jobs.parexel.com/functional-service-provider Apply To This Job