Job Description

Position overview:

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. The role will be focusing on budgeting/contracting. Experience on regulatory aspects can be considered as a plus.

Responsibilities include, but are not limited to:

· Development, negotiation and completion of country and site budgets.

· Development, negotiation and completion of contracts with sites and local thirty party vendors.

· Oversees and tracks site payments and payments to the third party vendors on agreed timelines adhering to the approved budgets

· Performs payments’ reconciliation at study close- out.

· Oversees antibribery process.

· Manages local sourcing of drugs and ancillary supplies management, importing and exporting requirements, supplies destruction.

· Enters and updates country information in clinical and finance systems.

· Develops local SOPs. 

· Coordinates and liaises with local team, HQ functional areas and third party vendors to ensure country deliverables are obtained for EUCTR submissions, budgets, contracts and local milestones. 

· Interacts and works in partnership internally with local clinical team, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with investigators, sites, hospitals, financial administrative bodies, local thirty party vendors (eg private local labs) and Regulatory Authorities.

· Contributes to initiatives and projects adding value to the business, as appropriate/required.

· Contributes to local clinical team by acting as Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement as appropriate/required.

Qualifications and experience:

· Minimum 2 years of experience as start up manager responsible for the financial aspect of interventional clinical trials.

· Bachelor’s Degree is required. Master’s degree would be a plus.  

Skills:

· Knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes and understanding of how these impact study start-up.

· Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.

· Excellent verbal and written skills, in Greek language and English.

· Strong coordination, negotiation and presentation skills.

· Ability to interact with investigators and vendors to address and resolve issues.

· Ability to make decisions independently with oversight from manager.

· Effective and efficient time management, interpersonal skills, conflict management and problem-solving skills.

· High sense of accountability and urgency in order to properly prioritize deliverables

· Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

· Positive mindset, growth mindset, capable of working independently and being self-driven.

Extent of travel: minimal travel required.

Location: Athens, Hybrid model of work is eligible.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R329150