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Sr. Manager, CRM, GCTO

4 months ago

Trenton, United States MSD Malaysia Full time

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 from feasibility 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 & Experience Skills: • 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, and 5) 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) 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: Regular

Job Description 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 from feasibility 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 & Experience Skills: • 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, and 5) 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 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: Regular

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s):

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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