Study Start Up Specialist (with Italian)

Germany·BerlinRemoteFull-time, Permanentmid

Laboratory & Life SciencesStudy Start-Up Specialist

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Overview

Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities.

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Laboratory & Life SciencesStudy Start-Up Specialist

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.

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.

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.

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 Italian language skills.

Home-based.

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