Senior / SSU Specialist job in Berlin, Germany

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: Germany

This vacancy has now expired. Please see similar roles below...

Proclinical is looking for and experienced Clinical Study-start up specialist . In this role you are responsible for conducting and facilitating specific start up activities that may include site identification, feasibility and document review. This is a Homebase role working from anywhere in Germany.

Job 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.
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).
Facilitates process improvement efforts both within the department and in cooperation with other departments.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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