Clinical Trial Manager

Based in Basildon (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

Permanent or FTC role

If you are an exceptional clinical trials professional looking for a new and varied role with a fast-growing international business, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands, and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role

Reporting to Head of Clinical Development, as Clinical Trial Manager you will be responsible for the overall management of clinical trials, from protocol development to study completion. Working closely with different departments like Regulatory, Medical Affairs, Market Access, Strategic Marketing, Legal etc. you will oversee the trial design, execution, scientific advice gathering and medical writing pertaining to all clinical studies required to deliver the pipeline of life cycle management strategies, as well as novel products and new chemical entities being licenced into the pipeline.

You will also act as the main point of interaction with external CROs, help in identifying best partners to appoint for trial execution and support, as well as ensuring each clinical study protocol is designed with scientific integrity with the endpoints clearly addressing the study objectives in line with the CDP and business needs. You will ensure GCP and other regulatory standards of all trials including IITs.

The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment

Main responsibilities and duties

• Protocol development: Developing and implementing study protocols in collaboration with clinical research physicians and other stakeholders like CRO (if outsourced). Being involved in designing study procedures, selecting study endpoints, and developing study timelines and budgets.
• Budget and resource management: Overseeing the budget for clinical trials and ensuring that resources are allocated appropriately. Includes managing staff, equipment, and supplies, as well as monitoring expenses and identifying cost-saving measures.
• Vendor/staff management: Recruiting, training, and supervising vendors/staff, including clinical research associates and data managers. Ensure that vendors/staff are properly trained on study protocols and that they follow GCP guidelines and other regulatory requirements.
• Study conduct: Ensuring that trials are conducted in accordance with protocols, regulations, and ethical principles. Includes overseeing recruitment and enrolment of study participants, monitoring study progress, 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 as well as ensuring that 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. Including monitoring study conduct, data management, and documentation to ensure that all activities are conducted in accordance with GCP guidelines and other regulatory requirements.
• Communication: Liaising with study CROs, principal investigators, and other stakeholders to provide regular updates on study progress and to address any issues or concerns that arise during the course of the study.
• Risk management: Identifying and managing potential risks associated with clinical trials, including developing risk management plans, monitoring adverse events and protocol deviations, and implementing corrective actions as needed.
• Regulatory compliance: Ensuring that clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines, MHRA/EMA/FDA/DCGI regulations, and other regulatory standards. Ensuring that all study documentation is complete and accurate and that all regulatory requirements are met.

About you - what you will need to have

• Bachelor's or Master's degree in a health-related field.
• Minimum 5+ years of experience in clinical trial management.
• Detail-oriented, analytical, and able to work effectively in a team environment.
• Demonstrable training in, and experience of utilising, project management techniques in the performance of clinical trials.
• Strong knowledge and experience of QMS working practices, GCP and other applicable regulations, and ensuring training in these areas is kept up-to-date at all times.
• Strong decision-making skills and organisational skills.
• Knowledge of budgeting and tracking.
• Strong knowledge of safety and ethics.
• Ability to coordinate site management with research activities.
• Experience with outsourcing and contracts within Pharma is preferred, or at least demonstrable knowledge of contracts, bid meetings and negotiations.
• Ability to work cross-functionally and foster strong partnerships within and outside the organisation.
• Track record of working and leading cross-function teams in a matrix environment.
• Ability to review both data and procedures in detail and the ability to see the greater overall picture.

What we offer

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 `

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.