Study Start-Up Specialist

1. Designation: Manager
2. Role: Study Start Up Specialist
3. Minimum Experience: 5+ Years
4. Qualification: Degree in Life Science
5. Location: Amsterdam
6. Reporting to: YTD

How would you describe this position in 2-3 lines?
The position is to support global regulatory submissions for clinical trials as it pertains to all of SPARC's development programs and life cycle management of My clients programs. The individual will be involved in creating, reviewing, approving, and/or submitting regulatory submission packages to global RAs in order to obtain approval to conduct clinical trials in those countries. In addition to RA submissions, this role will support study teams and site staff in submissions to local ECs/IRBs. As part of these responsibilities, the incumbent will review and approve essential documents for assigned studies.
This position will also handle site contracts.

Primary Responsibilities:
* Follow up with all stake holder departments to obtain technical documents required for Regulatory submissions.
* Preparation of documents for regulatory submissions
* Critically review documentation for submissions for consistency and quality as per relevant regulations.
* Essential document review and/or approval
* Coordinate with stakeholders to ensure timely and accurate submissions.
* Maintain annual approvals.
* Establish site budget template for assigned studies
* Establish per patient grants for assigned studies
a. Determine and document FMV analysis and justification for site and patient budgets
* Negotiate contract terms, pricing and payment schedule with investigators
* Overall- coordinate with internal & external stakeholders/legal/ finance & to execute/manage investigator contracts.
* Develop and maintain database of investigator contracts, agreed upon language, and budgets

Background: Candidate needs to have site start-up experience (regulatory and site contract).

Skills and Competence:
* Thorough understanding of ICH requirements and regulations.
* Regulatory submission experience globally (clinical trials).
* Regulatory agency direct interaction experience preferred. Expected to handle projects as independent contributor.
* Strong Financial skills related to budgets, costs, rates, contracts
* Strong Analytical thinking with excellent verbal and written communication skills.
* Ability to establish and maintain effective working relationships with your internal and external stakeholders.
* Fully conversant with MS Office and an expertise in Excel.

All the roles in the Netherlands are hybrid, office is in Amsterdam, need to be in 50-50.
Salary bandings for the roles will follow.