Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
ISR Study Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide operational expertise and will focus on studies including Investigator Sponsored Research & other study types. Study managers act as a matrix leader for operational support team(s) and are accountable for the timely execution of NRDG trials
- Ability to manage simple to complex protocols within a complex matrix environment. Demonstrates the ability to drive clinical trial activities: i.e. experience in all aspects of study start-up and maintenance, regulatory obligations, adverse event reporting, budget awareness, and experience in working with Contract Research Organizations (CROs) or external vendors (IVRS/IXRS).
- Demonstrates project management skills including project planning and prioritization, timeline management, time and meeting management skills, and ability to identify and manage or escalate risks.
- Ability to form positive working relationships with stakeholders and effectively management ability; effectively communicates and aligns with other departments; contributes to cross functional teams, task forces, or local and global initiatives.
- Vendor management ability; able to coordinate multiple vendors to support clinical research
- Understanding of ICH/GCP Guidelines and local regulatory guidelines or regulations; knowledge of clinical trial conduction and data review; knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.
- Effective oral, written and interpersonal communication skills
- Experience with conflict and issue management .
- Ability to learn new technology and effectively use Clinical Trial Management Systems (CTMS) and other technology platforms.
- Demonstrated ability to multi-task and manage high performance demands.
- At least a minimum of 3 years experience working within the pharmaceutical or CRO industry.
- Minimum education BA/BS.