Supervisor Clinical Data Management
US Mattawan, MI, US, 49071
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
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
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.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. 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.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
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