Clinical Trials Leadership Opportunity

1 week ago


Basildon, Essex, United Kingdom Ortolan Group Full time

A Competitive Salary plus Bonus and Rewards Package Awaits a Clinical Trial Manager at Pharmanovia

About the Role:

As a Clinical Trial Manager, you will be responsible for overseeing the overall management of clinical trials from protocol development to study completion. Reporting to the Head of Clinical Development, you will work closely with various departments to ensure trial design, execution, scientific advice gathering, and medical writing meet regulatory standards.

You will also act as the primary point of interaction with external CROs, help identify best partners for trial execution, and support ensuring each clinical study protocol is designed with scientific integrity. Your key responsibilities will include:

  • Protocol development: Developing and implementing study protocols in collaboration with clinical research physicians and stakeholders.
  • Budget and resource management: Overseeing the budget for clinical trials, allocating resources, managing staff, equipment, and supplies, and monitoring expenses.
  • Vendor/staff management: Recruiting, training, and supervising vendors/staff, including clinical research associates and data managers, ensuring they follow GCP guidelines and other regulatory requirements.
  • Study conduct: Ensuring trials are conducted in accordance with protocols, regulations, and ethical principles, overseeing recruitment and enrolment of study participants, and managing study documentation.
  • Data management: Ensuring the integrity and accuracy of clinical trial data by overseeing data management activities, including data collection, analysis, and reporting, and ensuring data is stored securely and in compliance with regulatory requirements.
  • Quality control: Developing and implementing quality control measures to ensure compliance with regulatory requirements and standards, monitoring study conduct, data management, and documentation.
  • Communication: Liaising with study CROs, principal investigators, and other stakeholders to provide regular updates on study progress and address any issues or concerns that arise during the course of the study.
  • Risk management: Identifying and managing potential risks associated with clinical trials, developing risk management plans, monitoring adverse events and protocol deviations, and implementing corrective actions as needed.
  • Regulatory compliance: Ensuring clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines, MHRA/EMA/FDA/DCGI regulations, and other regulatory standards.

About You:

We seek an experienced Clinical Trial Manager with a Bachelor's or Master's degree in a health-related field, minimum 5+ years of experience in clinical trial management, and demonstrable training in project management techniques. You should have strong knowledge and experience of QMS working practices, GCP, and other applicable regulations, as well as decision-making skills, organisational skills, and knowledge of budgeting and tracking.

The ideal candidate will be able to coordinate site management with research activities, work cross-functionally, and foster strong partnerships within and outside the organisation. A track record of working and leading cross-functional teams in a matrix environment is desirable.

What We Offer:

A competitive salary plus bonus and rewards package, including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working arrangements.



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