Clinical Operations Manager
hace 1 mes
Job Description
We invite you to join out team
This role is accountable for performance and compliance for assigned protocols in a country in compliance with regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Senior Clinical Operation Manager, Head Clinical Operation Managers or Clinical Operation Director, the person is responsible , for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Requirements:
- Bachelor’s degree in Business Administration, Life Sciences or equivalent
- Five (5) or more years of regulatory experience (End to End process, collaboration with key external partners, among others)
- Proficiency in English and Spanish, in oral and written.
- Willing to travel up to 5% of the time.
Skills:
- Expertise of core clinical systems, tools, and metrics
- Effective coordination, problem solving, and organizational skills.
- Local regulatory environment and submission and approval processes and understanding of how this impact study start-up.
- Ability to influence different internal and external stakeholders for example site staff, investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from Clinical Research management team.
- Ability to make decisions independently with limited oversight from Management.
- Understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
- Ability to lead a team of Clinical Trial Coordinators as applicable.
- Ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills
- Accountability and urgency to properly prioritize deliverables.
- Effective communication, leadership, and negotiation skills
- Ability to focus on multiple deliverables and protocols simultaneously is essential.
- 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.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
YesHazardous Material(s):
N/ARequisition ID:R287952
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