Study Start Up Specialist - Home based Germany - Perm
- Contract Type
Novella Clinical is looking for an experienced Clinical Study Start-up professional in Germany to join our new Study Start-Up Unit. The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document collection and review, ICF customization, EC and CA submissions, preparation and negotiation of Clinical Site Contracts for Germany.
This is a new and pivotal position within the European operation as we look to streamline the start-up process and introduce the Study Start up department.
Key Skills & Responsibilities:]
- Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to SSU manager on site performance metrics.
- Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
- Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.
- Responsible for the translation and co-ordination of translations for documents required for submission.
- Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
- Work with legal team members and SSU Manager to secure authorization of contracts.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- May participate in feasibility and/or site identification activities.
- Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
- Collects and reviews initial regulatory packets and site contracts for investigator sites.
- Assures that SSU functions interface effectively with all other key operating departments within Novella. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Create, review and customization of country/site specific Informed Consent Forms (ICFs).
- Participates in business development activities to grow Novella’s business.
- Facilitates process improvement efforts both within the department and in cooperation with other departments.
If you would like to discuss this role and department in more detail I would be pleased to receive your CV and set up a call to go over the details. This is a great opportunity to join a new department and make a huge impact in the direction and service provision of Novella Clinical.