Sr. Manager CRM GCTO

This role is primarily accountable for the end-to-end performance and project management forassigned 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.
Provide a key support role to TA-Head / CRD to effectively manage team, volume of clinical trials, and local/regional or global projects.
The Sr.
CRM (Senior Clinical Research Manager) may be responsible for managing a specific study for several countries within a cluster.Responsibilities include, but are not limited to:
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).• May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.• Responsible for project management of the assigned studies:
pro-actively plans, drives andtracks execution and performance of deliverables/timelines/results to meet country commitments fromfeasibility and site selection, recruitment, execution and close out.• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards andadverse event reporting requirements internally and externally.o Reviews Monitoring Visits Reports and escalates performance issues and trainingneeds to CRA-Manager and/or functional vendor and internal management as needed.o Performs Quality control visits as required.• Leads local study teams to high performance:
trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).• Responsible for creating and executing a local risk management plan for assigned studies.• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.• Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT(as appropriate).• Identifies and shares best practices across clinical trials, countries, clusters.• May act as a mentor.
• Responsible for collaboration with functional outsourcing vendors, investigators, otherexternal partners in assigned studies.• Country POC for programmatically outsourced trials for assigned protocols.• As a customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials.
Consult with Global Human Health BU as needed.Qualifications, Skills & ExperienceSkills:
• Expertise in project and site management.
The position requires demonstrated successful implementation of project management skills at program and site level.
• Strong organizational skills with demonstrated success required.• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies andcommitments.• Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.• Strong scientific and clinical research knowledge is required.
Including extensive knowledge of regional and/or country clinical trial landscape.
• Deep understanding of the organizational structure of our R&D Department and cross-functional roles and responsibilities of its members.
• Strong understanding of clinical trial planning, management and metrics is essential aswell as the ability to focus on multiple deliverables and execute complex protocols simultaneously.• Experience functioning as a key link between Country Operations and Clinical Trial Teams.• Communicates effectively and fosters a collaborative spirit in a remote/virtual environmentand across countries, cultures and functions.• Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity,quality and project and/or program delivery.• Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly.
• Proficiency in written and spoken English and local language.
The incumbent must be competent and effective in written and verbal communication.• Strategic thinking.• Ability to work efficiently in a remote and virtual environment.• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.• High emotional intelligence• Ability to focus on multiple deliverables and protocols/projects simultaneously.• Exercise strategic thinking and executes effectively across projects• Fosters understanding of cultural diversity.• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our R&D Department, Global Clinical Development and Global Clinical Trial Operations.• Ability to identify problems, conflicts and opportunities early and lead, analyze and creatively prepare mitigation plans and drive conflict resolution is critical.• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.
Examples of common problems include:
1) low patient recruitment,2) inadequate staff to meet business needs,3) performance or compliance issues,4) working with regulatory issues and the broader organization, and5) resolution of conflictive situations.• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.Qualification & Experience:
Required:
• 10+ years of experience in clinical research with demonstrated success and increasing responsibilities of which 5+ years consisted of leading projects• Bachelor degree in Science (or comparable)Preferred:
• CRA Experience preferred• Advanced degree, (e.g., Master degree, MD, PhD)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:
Shift:
Valid Driving License:
Hazardous Material(s):
SummaryLocation:
CHN - Beijing - Beijing (Wangjing Park)Type:
Full time