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Director, Site Management and Monitoring (REMOTE)

at Merck in Dover, Delaware, United States

Job Description

Job Description

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 in executing GCTO strategy. The position will directly impact country/region ability to reach business targets and objectives. Under the oversight of the Head of SMM/ESD, the person is responsible for monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables. The role has 5 – 12 direct reports (CRA manager) and has indirect oversight of 40 to 150CRAs. 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, company SOPs and ICH GCP, Monitoring Excellence, Vendor management. Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.

Responsibilities include, but are not limited to:

+ Responsible for country 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 (company and partners). Ensure metrics are met at expectations.

+ Accountable for resource and talent management of our company’s CRAs and CRA managers in region. 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 company CRAs. Supports recruiting efforts (interviews, hiring).

+ Collaborates internally with 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 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 Clinical Research Guidelines and ability to work within these guidelines.

+ Metrics development and management.

Behavioral 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 integrationinto 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

MRLGCTO

\#EligibleforERP

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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Job Posting: JC229030484

Posted On: Nov 20, 2022

Updated On: Dec 05, 2022

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