MSD Clinical Operations Manager 

Greece, Attica 

468946127

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 but experience on regulatory aspects is also needed.

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:

• 3-5 years of experience as start up manager responsible for the financial aspect of interventional clinical trials.

• Required: Associate Degree or equivalent Health Care related experience

• Preferred: Bachelor’s degree

Skills:

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

• Knowledge of core clinical systems, tools and metrics

• Excellent verbal and written skills, in local language and English

• Strong coordination and organizational 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.

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

• Ability to make decisions independently with oversight from manager.

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. ICH/GCP knowledge appropriate to role.

• Able to work with other experienced clinical research professionals and manage selected protocols independently. Works with high quality and compliance mindset.

• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / Contract negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

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

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

• Strong communication and negotiation skills as well as developing skills in influencing and training/mentoring, both written and verbal, in local language and English.

• 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.

Current Contingent Workers apply

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