Clinical Trial Manager
1 week ago
Essential Pharma are looking for a Clinical Trial Manager to lead the overall management and oversight of clinical trials. We are looking for someone able to join us in October/November ready to work on delivering a treatment essential for patients facing a treatment of newly diagnosed high-risk neuroblastoma. Apply Today
What You Will Do
Reporting into the VP for Rare Disease you will lead on:
- Study planning and execution, developing detailed project plans, including timelines, budgets, and resource allocation.
- Regulatory compliance, ensure all trial are conducted in compliance with GCP, FDA regulations, and other applicable regulatory requirements.
- Manage the preparation and submission of regulatory documents, including INDs, IRBs, and ECs.
- Management of sites, data and vendors.
- Mentoring and management as the team grows.
- Budget, resource and risk management.
- Communication and collaboration, ensuring regular updates to senior management on trial progress and milestones, preparing and presenting trial status reports.
What We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland.
What You Will Bring
- Degree or equivalent in life sciences, medical science or nursing.
- Clinical trial management experience gained in a Clinical Trial Manager role with a proven track record of managing clinical studies.
- Global regulatory knowledge (including the US), experience of biologics, oncology and pediatrics would be highly desirable.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
What We Offer
- Salary – from £80,000
- Agile Working – we offer flexibility and trust from day one, when you attend the office will be guided by business needs and role requirements. This role requires you to work a least one day per week from our Egham, Surrey office and one day per week in London with flexibility according to business needs.
- £150 towards your home office – claim purchases back on expenses.
- Healthcare Insurance
- Pension – you contribute 5% and we offer 3%.
- Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
- Enhanced Family Leave
- Enhanced Sick Pay
- Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
- Discretionary Annual Performance Bonus
- Recognition Program – from shout outs, vouchers and up to £2000 for gold awards
What To Expect
- We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
- Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
- Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
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