Clinical Operations Manager Lead
1 mese fa
Minimal travel required.QualificationsEducation 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 languageBehavioral 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 HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:RemoteShift: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. SummaryLocation: ITA - Lazio - RomaType: Full time
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