Clinical Operations Manager

2 months ago

Budapest, Budapest, Hungary MSD Full time

Job Description

Regulatory Clinical Operations Manager

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM or CRD, the person is responsible for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to:

  • Executes and oversees clinical trial country submissions and approvals for assigned protocols.
  • Develops local language materials including local language Informed Consents and translations.
  • Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
  • Contributes to the development of local SOPs. Oversees CTCs as applicable.
  • Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions and local milestones. Collaborates closely with Headquarter and at regional level to align country timelines for assigned protocols.
  • Provides support and oversight to local vendors as applicable.
  • Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
  • Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially but not limited to during study start-up.
  • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions.
  • Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
  • Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Core competencies:

  • Expertise of core clinical systems, tools and metrics.
  • Excellent verbal and written influencing and training/mentoring skills, in local language and English.
  • Strong coordination and organizational skills.
  • Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
  • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM or manager.
  • Ability to make decisions independently with limited oversight from SCOM or manager.
  • Requires strong understanding of local and regional regulatory environment, both current and related to EU CTR implementation.
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  • Knowledge of EU CTR changes both at the regional and country levels,

Behavioral Competency Expectations:

  • Problem solving is essential to this position. Requires the 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: 1) Quality and compliance issues, 2) Regulatory and legal issues, and 3) 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, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, 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,
  • Able to directly influence site staff

Experience Requirements:

Required:

  • 5 years of experience in clinical research or at least 2 years of experience in clinical research in areas of HA/EC submissions, start-up and regulatory aspects.

Educational Requirements:

Required:

  • Bachelor's Degree in Administration/ Life Science or equivalent Health Care related experience.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/11/2024

*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:08/11/2024

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:R304737

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