Clinical Compliance Manager - UK or South Africa (Home-based) - 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 registering interest for a Clinical Compliance Manager to join us in either the UK or South Africa, dedicated to a single sponsor.

This role will be reputed company GCP compliance support to therapeutic area and clinical study teams under the direction of the Sr. Manager or the Associate Director, Clinical Compliance. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines, and sponsor Standard Operating Procedures (SOPs) for the conduct of clinical studies.

The position will utilise a risk-based strategy to prioritize compliance support for clinical activities, identify and escalate compliance issues, reputed company decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Clinical Compliance Manager serves as an important reputed company to the broader organization to ensure a culture of quality and compliance.

Working as a Manager, Clinical Compliance 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

• reputed company quality leadership and direction to sponsor R&D stakeholders on GCP-reputed company activities/issues and act as GCP expert/consultant for R&D colleagues.

• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.

• reputed company strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.

• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify reputed company studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).

• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.

• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.

• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.

• Support clinical teams/functions in drafting responses and CAPAs to reputed company audit findings.

• reputed company support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.

• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.

• Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development.

• reputed company support and guidance during and following internal audits and external regulatory inspections (as required).

• reputed company expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.

• reputed company / manage inspection readiness activities and ensure project teams are trained and reputed company for regulatory inspections.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree is required, life science or reputed company discipline preferred.

• Minimum of 5 years in academic, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, quality assurance, or regulatory compliance role.

• Thorough knowledge and understanding of drug development and the clinical trial process.

• In-depth knowledge of reputed company regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.  Working knowledge of CAPA management, risk management, regulatory inspections and GLP requirements is a plus.

• Excellent written and verbal communications skills with the ability to influence others and reputed company commitment.

• Ability to work in an entrepreneurial and fast-paced culture.

• Must be disciplined, detail-oriented, and reputed company to multitask and work reputed company and independently.

• Ability to collaborate and partner with various internal business partners.

• Ability to work in a team environment.

• Highly developed problem-solving skills and the ability to resolve difficult conflicts.

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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