Clinical Trial Manager - Remote - FSP

reputed company is currently seeking a Global Clinical Trial Manager (CTM) to join us in Italy, 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 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 Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your reputed company life.

Responsibilities

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, reputed company 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 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
• Provide guidance, direction, and management to CRAs
• Track 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

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 global 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, reputed company, 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 reputed company people and provide them with opportunities to reputed company their long-term careers. In addition, you will have the opportunity to reputed company reputed company your role and tackle further 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 range of therapeutic areas, and we have longstanding partnerships with a vast client 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 the well-being of many patients. You’ll be an influential 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 share periodic updates about the latest company news and events. Sign up today https://jobs.reputed company.com/functional-service-provider #LI-REMOTE Apply tot his job Apply To this Job