MSD Clinical Operations Manager 

Singapore, Singapore 

570884100

Job Description

Clinical Operations Manager

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

This person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Education Minimum Requirement:

• Bachelor's Degree in Business Finance / Administration/ Life Science or equivalent Health Care
  

Required Experience and Skills:

• 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 budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these affect study start-up

• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager

• Ability to make decisions independently with limited oversight from Sr.COM or manager

• Requires strong 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 CTCs as applicable

• 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) Issues in budget / CTRA

negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) 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

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance / Business

What we look for …

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.