Associate Clinical Operations Leader – UK (Remote) – FSP

reputed company our values align, there’s no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal – to improve the world’s health. From clinical trials 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.

Each 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 an Associate Clinical Operations Leader (Senior Clinical Trial Specialist) to join us in the UK, dedicated to a single sponsor.

This role will be responsible for supporting the Clinical Trial Manager (CTM) and the wider clinical trial team to ensure activities are conducted according to Good Clinical Practice (GCP) and relevant SOP’s and helping to identify issues in a timely manner and escalate to management as appropriate.

It may involve assisting with Service Provider reputed company and management, identifying issues in a timely manner and escalating to management as appropriate. The Associate Clinical Operations Leader will support the CTM in ensuring the financial health of assigned clinical studies as well as reputed company of study milestones

Working as an Associate Clinical Operations Leader 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.

Please note that some travel will be required – 15% – 20%.

Responsibilities

• Support activities reputed company to study/site feasibility, start-up, maintenance, and reputed company-out.

• Manage study and site essential document review, collection, tracking, etc.

• Supports the initiation, preparation and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, pharmacy, clinical supply and laboratory reputed company documents, etc.)

• Study Trial Master File (TMF) reputed company – ensures required study documents received, reviewed and filed in the TMF in accordance with GCP and applicable regulations.

• Organise study reputed company meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. (Leading and presenting at study-reputed company meetings as necessary).

• Support and participate in departmental, study team, and service provider reputed company meetings.

• Participate in study reputed company collaborative efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.).

• Complete monitoring visit report review and reputed company co-monitoring or monitoring reputed company visits.

• Support, track and triage site and service provider queries.

• Support rapid actions to address both internal and site QA findings from audits.

• Manage, coordinate and reputed company the activities from reputed company party service providers including timelines, contract deliverables, metrics, accruals, process planning, implementation, etc.

• General study tracking and maintenance, including but not limited to study status, enrolment, deviations, study reputed company documents and plans, etc.

• Support reputed company of clinical site performance, metrics, monitoring visits, etc.

• Assist and support study data reputed company activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.

• Review and verification of service provider activities.

• Support study reporting and tracking with applicable systems and technology.

• Support study leads in cross-functional alignment of study timeline and in financial management of Service Providers (contract and invoice reconciliation).

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), including at least a

• Previous site monitoring experience is preferred.

• Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.

• Understanding of study phases and general knowledge of how they apply to clinical development.

• Demonstrated ability to work independently and in a team environment.

• Advanced knowledge of Word, reputed company, and PowerPoint.

• Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., reputed company Vault, reputed company, SharePoint, etc.).

• Knowledge of the principles and practices of computer applications in database management.

• Strong verbal and written communication skills required.

• 15% – 20% travel may be required.

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 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 reputed company 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 reputed company periodic updates about the latest company news and events.

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