Sr Manager, Study Management

Sr Manager, Study Management Req ID #:  100991 Location: 

Horsham, PA, US, 19044 For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Summary BASIC SUMMARY:

Manage the department and all functions related to the generation of protocols through the final protocol and the study report. Responsible for the daily activities of all report publishing functions to ensure local and global on-time delivery and quality requirements are maintained in the department. Liaise with colleagues across the Safety Assessment organization via formal and informal forums to ensure that efficiencies and best practice are implemented at the site.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensure timely preparation of protocols, in-life coordination in support and on behalf of study directors, methods development, table development and production of final report.

• Assure that areas of responsibility are in compliance with domestic and foreign Good Laboratory Practices and other applicable regulations.

• Engage key stakeholders across the organization, especially Study Directors, to resolve challenges in quality and delivery, improve efficiency, and refine processes as needed to meet business needs.

• Manage and resolve strategic study management issues within and external to the function.

• Oversee preparation of responses to both internal and external quality assurance audits.

• Manage activities of assigned group(s) to ensure optimum performance of the group/function.

• 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.

• Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.

• Assist in the development and recommendation of departmental budget and authorize expenditures.

• Develop and oversee the implementation of departmental training programs, including orientation.

• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].

• Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.

• Perform all other related duties as assigned.

Job Qualifications

QUALIFICATIONS:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in life sciences or related discipline.

• Experience: 3 to 5 years related experience, preferably within a GLP environment.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Certification/Licensure: None

• Other: Excellent verbal and written communication skills as well as organizational skills. Demonstrated independent analytical and problem-solving abilities. Ability to work effectively as a member of a team. Ability to work in a dynamic, detailed driven environment. Ability to handle multiple projects, prioritize work and meet deadlines. Computer proficiency in MS Word, Excel, Outlook and SharePoint. Proficiency in computer programs (e.g., Provantis) and procedures used to accomplish data reduction. Proficiency in document management systems, regulatory submission software (e.g., ISI Publisher, ISI Toolbox, AdLib) and experience using statistical analysis software (e.g., Nevis) is desired.

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 300 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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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.

Nearest Major Market: Philadelphia

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