Job title: Clinical Operations Manager Lead
Company: MSD
Job description: Be part of a high-performing team to drive strong results for the business and significant impact for customers. Exciting permanent full-time role based in Hong Kong. Join the premier biopharmaceutical company that has been in the business for more than 125 years and in Asia Pacific over 60 years.
WHAT YOU WILL DO
This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures, and with quality standards internally and externally. The person has ownership, oversight, and impact on local regulatory and financial compliance and for out-tasking as applicable. Under the oversight of the CRD, or Head of Country Operations, the person is responsible to manage/oversee a team of COMs and/or CTCs.
Responsibilities include, but are not limited to:
- Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
FINANCIAL:
- Ownership of country and site budgets. Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
- Interacts successfully with local clinical team/s to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:
- 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.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT:
- Responsible for managing country deliverables, timelines, and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/Int’l SOPs.
- Oversees contract workers (e.g. COMs and CTCs) and local vendors.
- Manages direct reports including performance plans and development plans. Effectively manages performance issues.
COLLABORATION:
- Works with minimal oversight from CRD or line manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, Local finance departments, legal, HQ functional areas and externally with vendors, sites, and other stakeholders to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
- Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.
LOCAL PROCESS OVERSIGHT:
- Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
- Enters and updates country information in clinical, regulatory, safety, and finance systems.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
CORE Competency Expectations:
- 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.
- 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.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Demonstrates leadership behaviours.
Behavioural Competency Expectations:
- Problem solving and Process Improvement is essential to this position.
- Ability to pro-actively identify issues and risks, analyse 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.
- Strong communication and leadership skills.
- Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
- 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 and understanding of cultural differences.
- Fluency in both English and local language.
Experience Requirements:
- Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
Educational Requirements: B.A./B.S. with strong emphasis in science and/or biology.
What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
Expected salary:
Location: Hong Kong
Job posting date: Thu, 26 Sep 2024 07:43:36 GMT
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