Local Start Up Specialist

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for a highly skilled and experienced **Local Start Up Specialist **with essential documentation collection, review and various submission expertise to join our team**.**

The Local Start-Up Specialist coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence Unit. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

The LSUS will be responsible for the following tasks:
**General activities**
- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
- Ensure planned dates are reliable and up to date in CTMS departments/study teams
- File documents in the (e)TMF for which they are the document owner
- Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

**RA submission/approval activities, if applicable**
- Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
- Provide relevant documents in compliance with local regulation
- Support review of technical, pre-clinical and clinical reports for regulatory submissions
- Interact with regulatory authorities
- Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
- Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
- Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

**IEC/IRB submission/approval activities**
- Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
- Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
- Interact with IEC/IRB
- Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
- Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
- Assist in adapting country SIS/ISF to site-specific requirements

**Essential Document collection activities**
- Assist in preparing the site-specific Essential Document Package and sending to sites
- Responsible for collection and first review of Essential Documents
- Provide the Global Essential Document Reviewer with the collected documents for independent review
- Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
- Obtain authorization for the shipment of Investigational Product to the site
- Track relevant information and data in CTMS and/or other tracking tools

**Other responsibilities as required such as**:

- Maintain current knowledge of guidelines and technologies appropriate for functioning in this capacity
- Maintain Allucent’s training as assigned based on role, department and/or project
- Support SSU staff learning & development within the company
- Contribute as Subject Matter Expert (SME) in the field of study start-up activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure good communication and relationships with (future) clients
- May participate in feasibility and/or site identification activities
- Contribute to other areas of business as required

**Requirements**:

- Life Science, Healthcare, or Biological Science degree and minimum 3 years of experience in drug development and/or clinical research
- Minimum 2 years’ experience in similar role or equivalent combination of education, training, and experience
- Good knowledge of GxP, privacy legislation (GDPR and/or HIPPA), and applicable local regulatory requirements
- Good knowledge of the country or region competent authority submission and reporting requirements and guidelines.
- Strong written and verbal communication skills including good command of English language
- Ability to work in a fast-paced challenging environment of a growing company
- Representative, outgoing and client focused
- Strong organization and time management skills
- Administrative excellence, with attentio