Senior eCOA Operations Specialist
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, United States
- Start date
- Sep 29, 2020
View more
- Discipline
- Clinical, Manufacturing & Production, Operations
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:
- Drives licensing with Global Outsourcing Manager, submission and retrieval of COAs from the COAM (Clinical Outcomes Assessment Management) library.
- Partners with cross-functional team members to ensure the initial eCOA study design, study build and deployment of devices across trials.
- Manages the eCOA implementation timeline.
- Acts as central point of contact for communication between the team and eCOA vendor on matters concerning translation availability and IRB/EC submission timelines. Escalates issues related to vendors as necessary.
- External review of eCOA-related CRO activities.
- Review of external eCOA-related activities: checks paper and eCOA deployment of instruments for accuracy and escalate issues to eCOA vendors.
- Accountable for stakeholder communications/change management and resolution/mitigation of issues and risks (escalate as appropriate).
- Contributes to internal/external continuous improvement initiatives/teams. (e.g., representation on eCOA SuperUser Network/COAM team).
- Drive process/system enhancements related to eCOA Specialist responsibilities/deliverables.
- Manage and comply with various quality and compliance systems
- Supports the study training needs related to eCOA instruments and management
- Leadsand supportson workstreams, projects andtraining of theeCOA Ops Team
Degree Requirements
Bachelor's degree required.
Experience Requirements
3-5 years of pharmaceutical, biotech, data/information technology experience preferably in the area of clinical trial, clinical outcome assessment, data, or technology management
- Project Management and planning skills, preferred
- Knowledge of GCP/ICH guidelines, regulations and BMS procedures/policies
- Ability to analyze and interpret complex issues and propose solutions
- Experience with team collaborations and driving innovation
- Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings
- Strong leadership capabilities
Key Competency Requirements
Effective oral and written communication skills, ability to influence cross-functionally, demonstration of leadership capabilities
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Company
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.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert