Associate Director, Clinical Study Management

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 19, 2020
Closes
Oct 07, 2020
Ref
2505
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for an Associate Director, Clinical Study Management (CSM) based out of our Rockville, Maryland, or Frederick, Maryland office. Emmes provides flexibility for the office location or work remote preference dependent upon position.

Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The CSM Associate Director, reporting to the CSM Director, is a member of the CSM Service Group and supports Emmes' mission of shedding light on important human health problems through scientific partnerships that result in innovative solutions. This is accomplished by successfully leading the CSM group to ensure that Emmes provides the highest possible quality and efficiency of operational support to Emmes' projects and its corresponding sponsors that create value to the projects.

Responsibilities
  • Communicates corporate goals to the CSM group and models corporate culture through vision, action, and learning
  • Provides direct supervision to CSM Managers who are responsible for resource management, training, quality of service to projects, and supervising the career paths of CSM staff
  • Responsible for holding direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability
  • Responsible for overseeing the contribution and maintenance of CSM SOPs and Work Instructions that accurately reflect the standards of activities falling under the responsibilities of CSMs. Will work to ensure cross collaboration with the other ClinOps verticals to maintain consistency
  • Ensures CAPA resolution for all CSM activities in a timely fashion and communicating proactively with QA representatives regarding ongoing resolution activities
  • Collaborates with the CSM Training Manager to provide internal and external training standards and manages to the training budget
  • Ensures CSM operations job descriptions and career paths are created, maintained, and communicated to the CSM members through the Managers
  • Creates high group engagement metrics (through Gallup and other means) across clinical operations for CSM staff
  • Identifies and tracks OKRs (Objectives and Key Results) for CSM ClinOps group
  • Ensure timely and comprehensive performance evaluations with direct reports, and for all staff within the CSM group in conjunction with the CSM Managers
  • Ensures internal and external CSM identification and project assignments meet project needs for current and future work, in collaboration with Talent Department and in conjunction with CSM Managers and CSM Hiring Manager
  • Provides the support required to the Proposal and Pricing Department to appropriately resource and price new business opportunities for tasks within the CSM purview

Experience
  • Bachelor's/Master's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO
  • Comprehensive knowledge of GCP, GDPs, and ICH E6 (R2)
  • Prior experience managing staff and/or in a mentorship role required
  • Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity
  • Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
  • Possess high degree of initiative and the ability to work independently
  • Professional maturity and wisdom to work through challenges in an expedient manner and push through issues to reach mutual outcomes across teams
  • Demonstrated strong problem-solving and analytical skills, combined with sound business judgment
  • Knowledge of hiring, supervision, coaching and evaluation of staff
  • Highly motivated with ability to work independently and as part of a multi-disciplinary team
  • Strong project management and time management skills


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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