At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson’s disease. We are highly committed to improving the quality of life for People with Parkinson's disease.

Clinical Trials Associate   

Reading | United Kingdom (GB) | Full-time | Permanent 

Objective

The post-holder is accountable for global execution and delivery of assigned studies across therapy areas to time, budget and quality as defined in the study protocol; in accordance with local regulations, ICH GCP / IND guidelines/Clinical Trial Regulation, and Britannia’s written standards. The post holder serves as the operational point-of-contact between the central study team and in-country operational staff (CRO), and other in-country staff aligned to the study, and provides excellent study management solutions to speed up the study deliverables with cost effectiveness.

Key Accountabilities

• Overall responsibility for the study commitments, within the portfolio and for timely delivery of data to required quality
• Responsible to provide leadership and drive decisions in conjunction with the Medical Affairs Manager related to the conduct of a clinical study globally/ regionally/ locally including escalating issues when required
• Responsible for project management of country and site-level activities including oversight of site management & monitoring activities, including timely Monitoring Visit Report review
• Serves as the operational point-of-contact between all internal and external stakeholders: Britannia representatives, Vendors (CRO, communication agencies …), the study team and in-country operational staff, including Clinical Research Associates (CRA) /and site staff, connected to the study.
• Responsible to identify and share best practices, and to drive process improvement at  a global and local level. Leads and optimises the performance of the Study Team(s) at global/ region/ country level via the CRO whilst ensuring compliance with Britannia’s Procedural Documents, ICH-GCP and local regulations.
• Coordinates the site selection process together with the local Affiliates (via CRO, where appropriate) by identifying potential sites/investigators, performing initial Site Quality Risk Assessment.
• Ensures timely submission of application/documents to Ethics Committee/Institutional Review Boards at start up, and for the duration of the study. Works together with Regulatory Affairs (via CRO, where appropriate) to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Raises and manages PO Number requests for relevant expenses
• Performs monthly study budget reconciliation and review of invoices related to the study (CRO, site payments, Pass-through costs …).
• Ensure oversight of all global/ region/ country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness,
• Ensures the set up and maintenance of the study (via thirds parties, where appropriate) in Clinical Trials Management System as well as websites as required by local laws and regulations
• Oversees, manages and coordinates (via CRO, where appropriate) monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans
• Reports study progress/update monthly to appropriate stakeholders in the business
• Develops, maintains and reviews risk management plan on a global study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed
• Plans and leads Global/ Regional/ National Investigator meetings, in line with local codes, as required
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at global/ regional/ country level
• Supports CRO with creation of site contract templates and ensures contract and site payment budget are in line with local and global regulations.
• Ensures accurate payments related to the study are performed according to local regulations and agreements in place.
• Ensures completeness of the electronic Trial Master File (eTMF) and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the business, where appropriate

Personal Specification 

• Scientific degree or equivalent experience (e.g. life science, medicine, clinical research, pharmacy etc.)
• Experience in clinical development or equivalent experience in the pharmaceutical or health-related field
• Extensive experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
• Extensive understanding of clinical research and clinical study management including management of a CRO, and the associated regulatory process and quality requirements
• Knowledge/experience in project management and matrix team interactions
• Excellent English language written and verbal communication skills. Strong negotiation skills.
• Effective at problem solving and conflict resolution

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with positive attitude, expert knowledge and an entrepreneurial spirit that enjoy friendly working environment in a global team. We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com