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Celgene Corporation

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide.At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.There are more than 300 clinical trials at major medical c... Read More

Address      86 Morris Avenue Summit, NJ 07901
Website      www.celgene.com
Holding      No Holding Details

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Senior Manager

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Completed Bachelor's degree or equivalent.
- Minimum of 5 - 8 years experience as a CTA, CRA, Study Manager or equivalent in the pharmaceutical or CRO industry.
- Line management experience.

Summary/Scope:

The Senior Manager for Clinical Trial Associates (CTAs) is responsible for overseeing the region CTA team including one or more line managers (Assoc. Manager/Manager level) and leading work process enhancement/implementation and management/development of the CTA team.

Responsibilities will include, but are not limited to, the following:

- Lead CTA work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Site Monitoring].
- Line Management of of CTA Manager(s) and Clinical Trial Associates (CTAs),'s. Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
- Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.
- Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports.
- Identify and address performance issues and training needs.
- Lead CTA resource planning, interviewing, hiring, training, mentoring, and personal development activities.
- Ensure timely and optimal allocation of staff relative to priority of projects in collaboration with other manager(s) to balance workloads across the regional CTA group.
- Promote a positive work environment and professionalism in work behavior, work ethic, mutual respect, innovation and accountability at all levels.
- Champion ‘customer service’ orientation including establishment/maintenance of optimal working relationships between CTAs and Study Managers (SMs) and all Study Team members, including vendors as appropriate.
- Lead strategic planning and process development/ implementation for the function, tracking timelines to remain on schedule, and developing contingency strategies, if needed.
- Develop CTA training materials as needed and provide training and on-boarding to new hires.
- Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
- Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations and with CR&MA.
- Lead/participate in the development and review of functional/operational procedures and in resolving complex operational problems.
- Ensure effective and efficient collaboration between internal customers and external providers (CROs). Liaise with internal (Study Management, Site Contracting, Central Services, etc.) and external (investigational sites and vendors) partners/stakeholders to assess CTA team processes/performance and opportunities for development/enhancement.
- Collaborate and work effectively with other CTA/CSA managers to establish high quality and efficient processes and ensure consistency and alignment throughout the team. Maintain clear lines of communication with CTA/CSA managers to ensure high quality deliverables are met.
- Manage personal career development by participating in company-sponsored and other training programs as needed to ensure that skills are developed, maintained, and focused accordingly.
- Perform necessary department administrative functions and additional tasks as requested.

Skills/ Knowledge/Experience Required:

- Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must..
- Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within Celgene and with vendors as appropriate.
- Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
- Demonstrated competency in leading process improvement efforts.
- Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
- Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology.
- Strong computer skills to include MS Office: Word, Excel and PowerPoint.
- Minimum of 5 - 8 years experience as a CTA, CRA, Study Manager or equivalent in pharmaceutical or CRO industry.
- Bachelor’s Degree or equivalent.

Key Competencies:

- Foster Teamwork: Fosters an environment where people value each other and recognize the importance of each role in the organization.
- Attract and Develop Talent: Ability to recognize, attract, recruit, hire and develop talent. Builds a culture that encourages learning and continuous improvement. Equips people with the tools, knowledge, and opportunities they need to develop themselves.
- Drive Execution: Sets clear expectations, monitors process, holds people accountable, rewards them appropriately and follows-up. Drives improvement in processes, products and services.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

not provided

Contact Name:

not provided

Job Duration:

not provided

Phone:

1-908-673-9000

Email:

not provided

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