Job Overview

Supervise staff and oversee daily departmental processes e.g.: employee management, scheduling daily activities, prioritization of the activities, on-time delivery, and application of process. Positively influence the team to adopt or implement process changes in support of Global Clinical Data Management initiatives. Ensure quality of work produced by staff and adherence to applicable policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for personnel management activities such as scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
• Act as point of contact for site Operations and/or Scientific for questions on Clinical Data Management deliverables.
• Review and revise staff availability in alignment with the Clinical Data Management schedule.
• Coordinate with applicable staff on answers to client's comments on shipped data packages.
• If needed, assist staff to get Scientist and/or Study Director input on needed information to complete data package.
• Alert management and responsible site study personnel of risks to delivery timelines.
• Ability to work independently and to escalate issues to management as required.
• Oversee daily operational activities and supervise assigned employees to ensure optimum group performance.
• Recommend short-range departmental objectives, organizational structure, staffing requirements, and succession plans.
• Participate in departmental and global initiatives to implement or improve processes.
• Attend and/or host internal or external meetings as appropriate.
• Mentor and train staff in support of business needs and team development.
• Develop, implement, and maintain data or process tools.
• Draft and/or update relevant SOPs and other procedural documents.
• Support the Manager as needed with administrative activities.
• All other duties as assigned.

Job Qualifications

• Education: Bachelor's Degree (B.S./B.A.); scientific discipline preferred.
• Experience: Minimum of four (4) years' experience in the pharmaceutical and/or biotechnologybased
  industry in GLP or GCP environment. Experience in supervisory/management preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute
  for the specific education and experience listed above.
• Certification/Licensure: No specific certifications or licensure required
• Other: Knowledge of CDISC's CDASH, SDTM, and Controlled Terminology Standards. Knowledge data output formats (.xml,.xpt, sas7bdat, ASCII, text, .DAT, .xlsx). Knowledge of Microsoft Office Suite and ability to perform basic computer functions commensurate with the job responsibilities. Familiarity with data analytics software (E.g. SAS), experience in use of SAS is a bonus. Excellent organizational skills and the ability to meet deadlines. Excellent communication (both written and verbal), leadership and negotiation skills. Ability to interact appropriately with clients and all levels of employees, while at the same time supporting the efforts of departmental teams.

COMPENSATION INFO:

The pay range for this position is $100,000 - $106,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Education

Four-year degree required

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

For more information, please visit www.criver.com.

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