Associate Director, eCOA Management

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Position Summary

The Associate Director, eCOA Management is a leadership role which is essential to the operationalization of the eCOA capability for BMS clinical trials and directly contributes to the BMS R&D pipeline. 

This role reports to the Head of Clinical Data Acquisition within Global Data Management and is based in New Jersey.  It is a full-time, office-based position with flexibility to work from home up to 50% of the time. 

Position Responsibilities

• Providing leadership for end-to-end eCOA operationalization, working closely with vendors, study teams, and other eCOA focused roles to ensure the eCOA capability is implemented successfully for studies, both for initial deployments and post-production changes.

• Working with stakeholders to proactively understand the book of work for studies using eCOA.  Ensuring eCOA Management resources are assigned to studies and initiatives and regularly monitoring workloads to avoid delays in delivery due to resource constraints.  Forecasting future resource needs based on the book of work.

• Streamlining processes, document templates, vendor and internal interactions to facilitate effective eCOA implementation for studies.

• Ensuring eCOA issues during study conduct are effectively resolved in collaboration with study team members and with vendors.

• Actively participating in the governance framework used to ensure effective collaboration with eCOA vendors and eCOA UAT vendors, including timely resolution of critical issues and input into eCOA vendor capability release plans and roadmap.

• Ensuring effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.

• Providing ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential.  Empowering and holding staff to high quality performance and delivery.

• Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.  Ensuring procedural documents are understood by the team and followed.

• Holding accountability to resolve complex issues and proactively develop solutions, within the function and across functions.  Using clear communications and collaborative strategies to drive to resolution.

• Leading continuous improvement activities, defining and implementing the changes required to create an industry-leading eCOA capability.

• Representing the function for Health Authority inspections and internal audits.  Ensuring preparations and follow-up actions are being completed effectively by the team.

• Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

• Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

• Developing strong and productive working relationships with key stakeholders throughout GDM/GDO/BMS and with eCOA vendors with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

• Representing the Company in interactions with key external partners as part of any committee or industry group relating to eCOA management.

Degree / Experience Requirements

• Bachelors degree required with an advanced degree preferred

• At least 7 years of global clinical trial expertise, including specific experience with eCOA capabilities and end to end eCOA implementation.  Successful track record of leading through influence, working across complex, global organizational matrices and effectively managing staff. 

Key Competency Requirements

• Deep understanding of the drug development process with proven expertise in clinical trial start-up/execution and end to end eCOA operationalization in a global arena.

• Strong technical expertise in the area of eCOA processes, designs, instruments and with clinical data acquisition/integration.

• Strong knowledge of industry leading tools and well versed in industry trends and emerging technologies supporting eCOA.

• Strong knowledge of GCP/ICH guidelines.

• Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.

• Proven experience with reviewing technical documents, writing documents, and applying Systems Development Life Cycle (SDLC) and system validation principles.

• Demonstrated partnership across various collaborative and industry forums.

• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)

• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team and to effectively collaborate with other stakeholders.

Travel: Potential need for periodic travel

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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