One of the best pharmaceutical companies in the world is looking for a Study Start-Up Specialist in combination with Country Project Management responsibilities. Are you a (lead) Clinical Research Associate and want to gain project management skills? Don't hesitate and apply today !
Job Description
The Study Start-up Specialist is responsible for all Study Start-Up related activities in the country/region, on assigned studies, overseeing and leading Study Start-Up activities in collaboration with other clinical research stakeholders.
The Country Study Specialist is responsible for providing project co-ordination and operational solutions to support Clinical Project Managers. The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.
Responsibilities
- The Study Start-Up Specialist updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
- The Study Start-Up Specialist executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines
- The Study Start-Up Specialist prepares country level Informed Consent Form and obtains ethics committees' and local regulatory authorities' approval & prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
- The Study Start-Up Specialist maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
- The Study Start-Up Specialist partners with Clinical Project Managers and Clinical Study Specialists to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations
- The Study Start-Up Specialist supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required
- The Study Start-Up Specialist liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
- The Study Start-Up Specialist submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs)
- In collaboration with Clinical Project Managers, the Study Start-Up Specialist identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
- The Study Start-Up Specialist is responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value in the country
- The Study Start-Up Specialist coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring quality and safety standards, regulations, timelines and budget commitments are met
- The Study Start-Up Specialist performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable)
- The Study Start-Up Specialist provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters
- The Study Start-Up Specialist supports/coordinates the negotiation of site budgets within Fair Market Value guidelines, budget plans and provides oversight for site payments per contract, as required
Requirements
- You hold a University degree, minimum Master in (Life)Sciences
- You have minimum 3 years Clinical Research Associate (CRA) experience
- Experience with Phase 1 or rare diseases is a big plus
- You have demonstrated knowledge and understanding of clinical trials and experience in managing projects
- You have demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country
- Previous line management experience/supervision of staff is preferred
- Previous experience managing projects is desirable
- You are trilingual in Dutch, French & English (written and spoken)
- You have good knowledge of Microsoft Office (Powerpoint, Excel, etc…)
- You are a team player and have a flexible mind-set to take on other tasks
- Existing right to work in Europe required
Benefits
- A full-time position with a permanent contract as a consultant via Oxford
- A balanced salary package based on your experience and fringe benefits (company car, fuel card, insurances, 12 ADV, ...)
- You will be able to work in one of the biggest pharma companies in Belgium
- You will enter an environment where a good work-life balance is very important
Vacancy number: 18437
