Clinical Trial Manager

IQVIA LLC; Reading; On-site; GBP 65,000 - 90,000; Full time

Job summary

IQVIA LLC in Reading, Berkshire, United Kingdom, is seeking an experienced Clinical Trial Manager to lead multicenter trials from initiation to study report. You will coordinate cross-functional teams, manage timelines and budgets, and ensure compliance with ICH-GCP and regulatory standards.

The role requires at least 4 years in biopharma and global clinical project management experience, with oncology focus.

Qualifications

• Minimum of 4 years' experience in the biopharmaceutical industry.
• Minimum 3 year or experience in Clinical Project Management at global level.
• Proven work experience and knowledge of Oncology therapeutic area.
• Bachelor's Degree or relevant degree with strong emphasis on Science.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Strong experience in vendor management.

Responsibilities

• Accountable to deliver trials on time, within budget, and with highest achievable quality.
• Assist in review, development and writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Lead the evaluation and selection of investigative, clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
• Collaborate with internal stakeholders and vendors to improve trial delivery.

Skills

Vendor management

ICH-GCP knowledge

Communication skills

Clinical trial management

Oncology knowledge

Global PM experience

Regulatory knowledge

Education

Science degree

Job description

sites; responsible for feasibility.Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co-monitoring visits, as needed.Develop and manage trials timelines, budget and priorities.Participate in data review and discrepancy resolution.Ensure set up and maintain all systems in order to plan and implement trials and track progress.Generate reports to update management on conduct of trial.Ensure appropriate clinical trial supply plans are implemented and managed.Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.Participate in monitoring study safety.Review key study quality metrics (e.g., eligibility, primary endpoint data, etc) and determine appropriate action in conjunction with study team.Assist with CRA and third party vendor training on protocols and practices.Lead the multi-disciplinary trials teams; include the study team meetings.Required Skills and QualificationsMinimum of 4 years' experience in
the biopharmaceutical industry.Minimum 3 year or experience in Clinical Project Management at global level.Proven work experience and knowledge of Oncology therapeutic area.Bachelor's Degree or relevant degree with strong emphasis on Science.Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.Strong experience in vendor management.Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.Experience in executing a wide range of clinical trial activities from initiation to clinical study report.Strong communication skills with internal teams, sites, and vendors.

• Please note This role is not eligible for UK visa sponsorship IQVIA is a leading global provider of
  The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client's project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.The Clinical Trial Manager provides input to the overall operational trials implementation, manages trials timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.Main ResponsibilitiesAccountable to deliver trials on time, within budget, and with highest achievable quality.Assist in review, development and writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.Lead the evaluation and selection of investigative, clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.SummaryLocation: Reading, Berkshire, United Kingdom; Zagreb, Croatia; Lisbon, Portugal; Barcelona, Spain; Prague, Czech Republic; Madrid, SpainType: Full time