Study Start Up Specialist (with French)

Alimentiv

Job Location:

Berlin - Germany

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Support Project Management Regulatory and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study start-up activities.

Role and Responsibilities:

1. Site Start-Up Packages

In cooperation with Project Management create study-specific start-up document package.

Distribute and follow up with sites to obtain the required executed documents.

Review content and correctness of returned documents from the sites in accordance with internal standards.

In conjunction with Regulatory Affairs ensure that the correct and complete packages are obtained within the planned timelines.

2. Site Contract and Budget Negotiation

In co-operation with Contract and Legal obtain feedback on suggested site and investigator contract language.

Act as main point of contact for sites to obtain feedback on budget and contract negotiations.

In conjunction with the Project Manager provide sites with the suggested study budget and negotiate within pre-approved margins.

3. Site Intelligence Tracking

Maintain site intelligence tracker with data related to specific requirements for study sites such as start-up timelines budget contract negotiation timelines and prerequisites patient recruitment data etc.

Provide input for suggested site list during start-up using past experiences with potential study sites.

4. Site Start-Up Planning and Tracking & Project Management Support

Act as main contact for study sites during start-up.

Develop and maintain relationships with study sites that will facilitate timely completion of start-up activities.

In conjunction with project management and CRAs plan start-up actions and provide expected SIV dates for individual sites based on previous start-up metrics as well as regulatory and IRB timelines.

Track progress of start-up activities in smart sheet and/or CTMS.

Maintain up to date knowledge ensure adherence and compliance with local regulatory requirements and associated documentation.

Provide support to project management with study related activities as required.

Qualifications:

Undergraduate university degree (Bachelor or Honors Bachelor) and Minimal Training (brief orientation or introductory training); less than 1 years related experience;
Or College Diploma/Degree and 1-3 years related experience with initial and On-going training.

Other:

Excellent communication skills.
Knowledge of start-up requirements for clinical sites.
Experience in working directly with clinical study sites through previous involvement in studies.
Very high sense of urgency.
Some financial responsibility (handling of small cash floats minimal spending limits can provide input during department budget creation).
Sets personal pace and content (significant scope for setting pace and action order within the context of tasks to complete).
Large number of regular contacts (team/unit members/vendors/clients occasionally difficult requiring patience and tact).
English and French language skills.

Working Conditions:

Home-based.

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Required Experience: