R&D Clinical Trials Assistant – 12 month fixed term contract Hemel Hempstead, England
Job description
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
Role purpose:
As part of a small team within our global oncology franchise, our CTA will provide support in maintaining project metrics (timelines, budget and deliverables including trackers and tools) for assigned projects, with consistent on-time and accurate delivery. You'll be adaptable and hands-on and ready to take on new challenges.
Key responsibilities:
- Support the AD Head of Clinical Operations and/or Head of Clinical Development, Oncology, to maintain project metrics (timelines, budget and deliverables including trackers and tools) for assigned projects, with consistent on-time and accurate delivery.
- Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
- Contribute to ensure project documentation (i.e., eTMF) is complete, current, stored appropriately and audit-inspection
- Performs detailed review of study eTMFs according to company SOPs and processes.
- Contribute to the development of outsourcing specifications for clinical trials.
- Arranges meetings logistics, drafts meeting agenda, and prepares meeting minutes.
- Interacts with other functions as directed, to complete assigned tasks.
- Support drug forecasting and management in collaboration with responsible line functions.
- Support tracking of trial level budget(s), vendor contracts/ work orders/ change orders, and invoices.
Qualifications
- BSc degree, or higher, in a relevant scientific discipline (e.g., biological science, pharmacy or other health related discipline).
Skills and Experience Required:
- Minimum of 2-3 years experience in a pharmaceutical, biotechnology company and/or contract research organization (CRO).
- Good understanding of the complete drug development process and biopharmaceutical industry in general.
- Excellent knowledge of ICH GCP and clinical trial design.
- Experience working in a cross-functional, multicultural matrix team environment.
- Enthusiastic and open attitude towards continuous professional development.
- Fluent in English language (verbal and written).
- Able to communicate effectively with a wide range of internal and external stakeholders.
- Excellent organizational, interpersonal, and planning skills.
- Able to demonstrate attention to detail.
- Able to work independently with minimal supervision, and as part of a broader team(s).
- Able to navigate ambiguity, adapt to change, and make rapid disciplined decisions.
- Financial acumen.
- Familiarity with Microsoft packages (Word, Excel, Power Point, Outlook, SharePoint) and ability to develop proficiency in
- Prior CTA experience preferred.
- Oncology, Immunology and/or Rare Disease experience and exposure to academic research would be preferred
“At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone's contribution and achievements can be appropriately rewarded.”
