Associate Director, IRT & COA Services:
Merck

CLI006938-en_US
Merck
Rahway New Jersey
Pharmaceutical
Description
Requisition ID: CLI006938

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.


The Associate Director is responsible for providing all aspects of supervision to individuals supporting development, validation and quality control of Interactive Response Technology (IRT) systems and Clinical Outcome Assessments (COA) systems within Global Data Management & Standards. Provides effective oversight to technology providers selected to design and setup up IRT / COA systems. Leads functional area process improvements and innovation related initiatives. Interacts effectively with project teams and serves as first line escalation path for timely issue resolution. Serves as a Subject Matter Expert for IRT and COA related process and technologies, and mentors other members of IRT and COA services. Responsibilities may include supervision of staff and interaction with individuals across multiple Merck sites under the guidance and direction of the Director, in compliance with Merck Policies and Procedures. Ensures effective interaction of IRT and COA services staff with business stakeholders to achieve established objectives. Provides career development opportunities and manages performance for the staff.


Primary Activities

  • Develops strong performance objectives for team that are closely aligned to IRT and COA services goals, makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, and sets priorities
  • Provides developmental opportunities for direct reports, including challenging growth assignments. 
  • Ensures direct reports receive appropriate training and mentoring to be successful in their assignments
  • Participates in the recruitment process 
  • Develops challenging but achievable objectives that clearly support stated organizational goals.
  • Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports value-added work and work-life balance, estimating length and difficulty of tasks and projects, anticipating and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level
  • Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts
  • Determines, collects, and interprets performance metrics. Identifies correction strategies and ensures they are implemented accordingly
  • Conducts management and functional area meetings, contributing expertise when necessary through formal or informal presentations
  • Keeps abreast of process, technology and regulatory changes both within and outside of Merck that may impact staff
  • May participate in or lead initiatives beyond IRT and COA Services (e.g. cross-divisional projects, cross-industry initiatives, etc.)
  • May support any other project or perform any other data management task deemed appropriate by management

Qualifications

Education: 

  • BA/BS in Biology,  Life Sciences, Computer Science, or related field

Required: 

  • 6 years experience in Clinical Data Management or Interactive Response Technology (IRT) systems or Clinical Outcome Assessments (COA) systems or related industry experience
  • At least 3 years of supervisory or management experience
  • Strong knowledge of the Drug Discovery or Drug Development Process, ICH and GCP guidelines
  • Working knowledge of database structures, IRT/Data Management Tools & Technologies

Preferred:

  • Strong organizational, time management, problem solving and project coordination skills
  • Exceptional communication skills(oral and written), with the ability to communicate with both the technical and business areas
  • Effective written and verbal communication skills 
  • Ability to negotiate, resolve conflict and engage in decision-making with vendors, and influence across functional areas and organizations
  • Ability to lead cross-functional teams and organize / manage multiple tasks at one time. Demonstrate leadership and project management skills; exceptional organizational,  and problem-solving skills

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Clinical Data Management
Other Locations:
Employee Status: Regular
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Company Trade Name: Merck
Basic Qualifications
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