MSD

Senior Clinical Operations Manager Denmark and Norway (BB-F891D)

Found in: Neuvoo DK

Description:

Job Description

Our Clinical teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Clinical Research teams push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

In this role you will be accountable for execution and oversight of local operational clinical trial activities and will have ownership, oversight and impact on local regulatory and financial compliance. As Senior Clinical Operations Manager, you will also be responsible for managing a team of Clinical Operations Managers and Clinical Trial Coordinators in Denmark and Norway.

Responsibilities:

  • impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up
  • Ownership of country and site budgets.
  • Interacting with local clinical teams in order to deliver clinical and financial contracts within fair market value.
  • Oversight and tracking of clinical research-related payments, payment reconciliation at study close-out.
  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.
  • Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments.
  • Collaborates internally with Clinical Research Managers, Clinical Quality Managers, Medical Affairs, PV, Regulatory Affairs, Business Compliance, local finance departments, legal, HQ functional areas, Regional Operations and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. 

    • The role reports to Executive Director Clinical Research Nordic & Baltic, Global Clinical Trial Operations (GCTO).

    Experience Requirements:

    Required:

  • 8 years of experience in clinical research
  • Minimum Bachelor's Degree (Master’s degree is preferred) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience. Master’s degree is preferred.

    • Competency Expectations:

  • 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
  • Extensive experience with clinical project management and coordination.
  • Extensive knowledge of local regulatory environment and submission and approval processes.
  • Additionally, for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
  • Problem solving and Process Improvement is essential to this position.
  • Strong communication and leadership skills.
  • Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
  • People management skills (also across countries) will be valued.
  • Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences.
  • Fluency in both Danish or Norwegian and English.

    • Application and further information

    Start the application process by clicking the application button. Application deadline is March 4th 2021.

    Who we are …

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    What we look for …

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

    INVENT.

    IMPACT.

    INSPIRE.

    Search Firm Representatives Please Read Carefully 
    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

    No relocation

    VISA Sponsorship:

    Travel Requirements:

    Flexible Work Arrangements:

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    Hazardous Material(s):

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