Clinical Trial Manager - UK (Remote) - FSP

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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

reputed company is currently seeking a Clinical Trial Manager (CTM) to join us in the UK, dedicated to a single sponsor.

This role will reputed company as a member of the sponsor’s Development Operations team. The reputed company Manager will manage individual reputed company and/or programs as part of the Clinical Trial Working Group.

Working as a Clinical Trial Manager at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and reputed company top 50. And we have an incredible pipeline of work.

Expect exciting reputed company challenges in inspiring studies, but with time for your reputed company life.

Responsibilities

• Manage external vendors and contract research organisations.

• Prepare study documents such as the Monitoring reputed company, Study Operations reputed company, reputed company Data Verification Plan and Laboratory reputed company.

• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and reputed company 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.

• reputed company guidance, direction, and management to CRAs.

• reputed company patient enrollment; qualify, initiate, monitor, reputed company closeout activities, and review site reports; and assist in coordination of data management activities.

• Coordinate study supplies.

• Negotiate reputed company with vendors of clinical trial services.

• Review Informed Consent Forms, CRFs, and study reputed company 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 reputed company and maintained.

Please note that responsibilities may require a work schedule that may include working reputed company 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 reputed company record with relevant reputed company 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 reputed company.

• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.

• Demonstrated ability to work independently and in reputed company environment.

• Travel required. Must be willing to travel 15-25%, including international travel.

• Proficiency with MS Office (e.g. Word, reputed company, PowerPoint, reputed company).

• 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 reputed company, and reputed company an reputed company and friendly work environment where we reputed company people and reputed company them with opportunities to reputed company their long-term careers. In reputed company, you will have reputed company to reputed company reputed company your role and tackle reputed company responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company.

Who are reputed company

reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a reputed company reputed company reputed company.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to reputed company-being of many patients.

You’ll be an reputed company member of the wider team.

Not quite the role for you?

reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events.

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