Head, Site Management and Monitoring - Remote

Job Description

Job Summary:

This position is responsible for key tasks related to site management, territory development and country study support. It is a critical role in the local GCTO country management team and supports the country/cluster CRD or Region Head in executing GCTO strategy in the territory. The position will directly impact country/cluster/region ability to reach business targets and objectives.

Under the oversight of the CRD or Region Head, the person is responsible for monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables. The role has 3 to 12 direct reports (CRA manager) and has indirect oversight of 40 to 150 CRAs.

As line manager the role is critical to develop key talents in the organization to ensure a pool of success in critical roles.

The role should ensure excellent study performance with strict adherence to local regulations,

Monitoring Excellence, Vendor management and can represent the CRD in local management if required. Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.

Responsibilities:

• Responsible for country or cluster monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables from the area across all projects and across all monitoring resources. Ensure metrics are met at expectations.
• Accountable for resource and talent management of our Company CRAs and CRA managers in territory. Manages performance of CRA managers, conducts performance evaluations, encourages high performance to agreed aims and objectives. Addresses low-performance situations and ensures development needs are addressed. Ensures CRA managers do the same with our Company CRAs. Supports recruiting efforts (interviews, hiring).
• Collaborates internally with Country TA Directors, CRD, CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to develop and build the territory of principal investigators and sites.
• Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.
• Oversight and management of local vendors and partners to ensure consistency across country monitoring organization. Will work closely with PLMs and CRA managers to ensure consistency across all monitoring resources. Also, accountable for quality and compliance in monitoring function and the development and execution of Strategic Quality Initiatives within the monitoring function.
• In conjunction with Monitoring Excellence develops monitoring resourcing strategies in the country/cluster with vendors and CRDs to meet current and future resource demands.
• Works with vendors, positions and places CRAs for greatest efficacy & effectiveness.
• Accountable for the overall oversight of all FSP CRAs.
• Collaborates and works closely with the other GCTO management roles, the GCTO Headquarter teams, quality compliance, finance, IT and HR.
• A member of the local Leadership Team for GCTO.
• Works closely with the Country/cluster Leadership team, sponsor and supports strategic initiatives across Global Clinical Development and Global Clinical Trial Operations.
• This position and direct reports have a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining regulatory requirements and compliance.
• The position will directly impact the country’s ability to reach business targets and objectives and build productive collaboration with internal and external business partners.

CORE Competency Expectations:

• Business and financial acumen.
• Strategic thinking.
• Ability to think cross-functionally and working across boundaries internationally.
• Ability to identify problems, conflicts and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
• Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills.
• Excellent ICH-GCP knowledge and knowledge of Good Documentation Practices.
• Very good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Metrics development and management.

Behavioural Competency Expectations:

• High emotional intelligence.
• Strong leadership and negotiation skills.
• Positive proven success in people management.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
• Demonstrated ability to build relationships with senior business executives.
• Influencing skills.
• Excellent interpersonal and communication skills, conflict management.
• Relationship management and networking: strong integration into local and HQ TA network and ability to build productive relationships with all parties.
• Effective time management.
• Effective communication with external customers (e.g. sites and investigators).

Experience Requirements:

Required:

• Minimum of 12 years´ experience within Pharmaceutical Industry.
• Minimum of 10 years´ experience in clinical trial organization.
• Minimum of 5 years´ experience in a functional management position.

Advantageous:

• CRA experience.
• Management of CRAs and familiarity with outsourcing and flexible resourcing models.

Educational Requirements:

Required:

• Bachelors degree in Science or equivalent healthcare experience.

Advantageous:

• Advanced degree, (e.g., MD, PhD, Pharm D, MS,)

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Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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