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Clinical Operations Manager Lead

4 mesi fa

Roma, Italia MSD A tempo pieno

Job Description

This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures and with quality standards, both internally and externally.

The person has ownership, oversight, and impact on local financial compliance and on regulatory or out-tasking, as applicable. Under the oversight of the CRD, or Head of Country Operations, the person is responsible for managing/overseeing a team of COMs and/or CTCs.

Responsibilities include, but are not limited to:

  • Having significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up;
  • Taking ownership of country and site budgets; development, negotiation, and completion of Clinical Trial Research Agreements (CTRA); oversight of legal aspects as applicable
  • Successfully interacting with local clinical team/s, in order to deliver clinical and financial contracts within fair market value;
  • Interacting and collaborating with our local legal office and our local finance office, as applicable;
  • Taking ownership of all clinical research-related payments, and oversight of all associated activities conducted within GCTO Italy. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country;
  • Being responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Being responsible for quality and compliance in assigned protocols within the country. Contributing to the development of local/Int'l SOPs;
  • Overseeing contract workers (e.g. COMs and CTCs) and local vendors;
  • Managing direct reports, including performance plans and development plans. Effectively managing performance issues;
  • Working with minimal oversight from CRD or line manager, in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas, and externally with vendors, sites and other stakeholders, to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones;
  • Collaborating closely with Regional Operations and/or Headquarters, to align country timelines for assigned protocols;
  • Providing support and oversight to local vendors, as applicable;
  • Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management;
  • Entering and updating country information in clinical, regulatory, safety and finance systems;
  • Contributing or leading initiatives and projects adding value to the business, as appropriate/required;
  • Being responsible for the execution and oversight of clinical trial country submissions and approvals for assigned protocols, and the development of local language materials, including local language Informed Consents and translations;
  • Working in partnership with IRB/IEC and Regulatory Authority, in submission and approval- related interactions for assigned protocols;         
  • Minimal travel required.

Qualifications

Education and Minimum Requirements:

  • Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience;
  • Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience is preferred;        
  • 8 years of experience in clinical research;
  • 2 years of people management or oversight experience.

Required Experience and Skills:  

  • Extensive experience with clinical project management and coordination;
  • Expertise of core clinical, regulatory, and financial systems, tools and metrics;
  • Extensive knowledge of local regulatory environment and submission and approval processes;
  • Strong coordination and organizational skills; ability to focus on multiple deliverables and protocols simultaneously is essential.
  • Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures;
  • Demonstrates leadership behaviors and People Management skills, also across countries;
  • Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager;
  • Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables;
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions;
  • Ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: Issues in budget / CTRA negotiations, Quality and compliance issues, Regulatory and legal issues, and issues related to functional area deliverables that could jeopardize protocol milestones.
  • Problem solving and Process Improvement is essential to this position;
  • Fluency in both English and local language

           

Behavioral Competency Expectations:

  • Strong communication and leadership skills;
  • Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal;
  • Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences.

           

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/25/2024

*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.


Job Posting End Date:08/25/2024


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:R304998