Senior Early Stage Studies Assistant

The incumbent is responsible for hybrid operational support including clinical trial logistics and compliance with essential documents and study milestone reports as well as the execution and support of clinical grants and agreements.

This hybrid operational function includes, but is not limited to:

- operational project support to the Early Stage Development Scientist, responsibility for in-house operational activities in compliance with our processes to initiate, execute and close out early stage clinical trials
- clinical trial agreements and study or study related budgets (planning, negotiation and maintenance), clinical grants payments and procurement activities to support clinical study programs

Essential tasks include, but are not limited to:

- Assemble and provide support for timely Clinical Trial Submissions
- Update, maintain Essential Documents Repository (“Trial Master File”); Assemble and track availability of all essential documents required for study conduct
- Responsible for periodic in-house reconciliation of all essential documents in the electronic Trial Master File
- Update, maintain and monitor Clinical Trial Management System to allow accurate project management and regulatory reporting
- Follow-up on release, return and destruction of Investigational Medicinal Product
- Set-up of blood/urine samples shipments
- Follow-up on ancillary supplies shipments
- Review compliance of site staff vs non study specific training requirements

Contracts Analyst activities:

- Review budgets in context (review budget vs protocol and agreement) and request documented approvals to allow timely regulatory submissions
- Prepare and execute Clinical Study Agreements based on approved templates
- Reconciliation of clinical study budgets
- Track clinical grant costs/payments versus contracts and payment milestones, execute payments
- Verify and generate grant payments/vouchers for investigator site and vendor payments
- Execute purchase orders and payment requests as required
- Run anti-bribery, denied persons screening checks and fact finding
- Obtain and follow-up Financial Disclosure as needed
- Generate and maintain/track disclosure agreements
- Assist in the review of Master Service Agreements and maintain agreements and price lists, in close collaboration with site or vendor, sr contracts analyst, manager, procurement, legal and other stakeholders as needed
- Use the company Grant Systems, SAP/COMET, ARIBA
- Support vendor relationship tasks / assignments with preferred suppliers and sites, process purchase orders, check and track invoicing
- Request and track other payments as needed
- Update and maintain data for benchmarking of study and sourcing costs
- Develops in and maintains direct working relationships with:

- HQ research procurement and global site agreements
- Site clinical and business staff, field monitoring staff
- country financial, clinical and legal departments, procurement

Your profile:

- Work experience in clinical research is an asset
- Understanding and knowledge of study protocols and study working documents, lab manuals, clinical study data etc.
- Interest in operational and financial aspects of clinical trials operations
- Bachelor or Master’s degree
- Very focused and detail and task oriented
- Excellent interpersonal skills and oral and written communication skills
- Data, spreadsheet, computer hardware/software proficiency, knowledge of excel
- Project and time management skills
- Good judgment, follow up and follow through
- Problem solving and decision making skills required

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R266151