Bristol Myers Squibb
Working with UsChallenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us.
Position
Summary:
The Associate Director, EDC Management, Global Library Liaison (GLL) is an essential role responsible for leading the business and technical design requirements of therapeutically aligned global libraries which reduce database build timelines, increase efficiencies/consistency across various therapeutic areas and reduce site burden.
The GLL closely collaborates with cross-functional teams, key decision makers, internal and external stakeholders during the development and continuous improvement of the global libraries.
The GLL strategically develops business and technical solutions to support build and maintenance of global libraries, improve overall efficiency within the study development and library development process.
This leadership role requires innovative, service oriented, cross-functional knowledge and is central point of contact to other functional areas.
The GLL also leads and participates in proof of concepts and feasibility analysis in developing optimal solutions, by engaging internal and external technical experts.
Key Requirements:
Deep understanding of the drug development process and clinical trial start-up/execution.
Proven expertise in EDC development, management, and implementation at the global level.
Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Influential leadership and communication capabilities with a proven ability to engage and inspire a geographically diverse team.
Strong knowledge of industry leading EDC tools (e.
g.
, Medidata Rave, Oracle/Inform, etc.
)
Job Description:
The Associate Director, EDC Management is a leadership role with oversight of EDC global library development, management, and implementation activities and directly contributes to the BMS R&D pipeline.
Associate Directors may be People Managers or Individual Contributors.
This role reports to the Director or Associate Director of EDC Management within GDM&CM and is a full-time, office-based position.
Responsibilities:
All Associate Directors may be responsible for the following but may focus on specific responsibilities as required by business need:
Providing proactive leadership of EDC management activities.
Leading the development/implementation of the global library strategy and structures.
Leading a team of Global Library Programmers who create/update the standard data collection objects in the global library.
Leading the EDC system implementation to ensure adherence to best practices and promotion of effective use by GDM&CM.
This includes internal EDC module connections (e.
g.
, Safety Gateway, TSDV) and external system integrations (e.
g.
, with the Clinical Trial Management System and Payment systems).
Leading the collaboration with EDC providers and internal stakeholders to ensure the systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the providers' roadmap.
Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
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.
Contributing to the development and application of smart systems/tools and optimal approaches to support the collection of data with a standardized approach.
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 electronic data capture capability.
Authoring procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals.
Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.
Developing and conducting training and/or mentoring team members on key activities and processes.
Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause.
Ensuring timely closure of CAPA actions.
Representing the function for Health Authority inspections and internal audits.
Ensuring preparations and follow-up actions are being completed effectively by the team.
Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.
Ensuring effective quality oversight and management of external partners (e.
g.
Function Service Providers, CROs, technology providers, etc.
) performing activities on behalf of BMS.
Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
Representing BMS in interactions with key external partners as part of any committee or industry group relating to data collection.
For people managers:
Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes.
Managing the book of work, assigning resources to work 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.
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.
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.
Assigning resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion.
Requirements:
Bachelors degree required with an advanced degree preferredAt least 7 years of global clinical trial expertise with a focus on EDC global library development, management, and implementation.
Successful track record of leading through influence, working across complex, global organizational matrices, and effectively managing staff (for People Managers).
Deep understanding of the drug development process and clinical trial start-up/execution.
Proven expertise in EDC development, management, and implementation at the global level (not just at a study level).
Strong knowledge of industry leading EDC tools (e.
g.
, Medidata Rave, Oracle/Inform, etc.
) and well versed in industry trends and emerging technologies supporting data collection.
Strong knowledge of GCP/ICH guidelines, industry standard practices and good programming practices.
Significant experience with inspection readiness and CAPA development.
Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Strong stakeholder management and project management skills.
Excellent oral and written communication skills.
Demonstrated partnership across various collaborative and industry forums.
Diverse and deep 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 and develop colleagues.
#LI-HybridIf 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
About the Company:
Bristol Myers Squibb.
Estimated Salary: $20 to $28 per hour based on qualifications.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us.
Position
Summary:
The Associate Director, EDC Management, Global Library Liaison (GLL) is an essential role responsible for leading the business and technical design requirements of therapeutically aligned global libraries which reduce database build timelines, increase efficiencies/consistency across various therapeutic areas and reduce site burden.
The GLL closely collaborates with cross-functional teams, key decision makers, internal and external stakeholders during the development and continuous improvement of the global libraries.
The GLL strategically develops business and technical solutions to support build and maintenance of global libraries, improve overall efficiency within the study development and library development process.
This leadership role requires innovative, service oriented, cross-functional knowledge and is central point of contact to other functional areas.
The GLL also leads and participates in proof of concepts and feasibility analysis in developing optimal solutions, by engaging internal and external technical experts.
Key Requirements:
Deep understanding of the drug development process and clinical trial start-up/execution.
Proven expertise in EDC development, management, and implementation at the global level.
Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Influential leadership and communication capabilities with a proven ability to engage and inspire a geographically diverse team.
Strong knowledge of industry leading EDC tools (e.
g.
, Medidata Rave, Oracle/Inform, etc.
)
Job Description:
The Associate Director, EDC Management is a leadership role with oversight of EDC global library development, management, and implementation activities and directly contributes to the BMS R&D pipeline.
Associate Directors may be People Managers or Individual Contributors.
This role reports to the Director or Associate Director of EDC Management within GDM&CM and is a full-time, office-based position.
Responsibilities:
All Associate Directors may be responsible for the following but may focus on specific responsibilities as required by business need:
Providing proactive leadership of EDC management activities.
Leading the development/implementation of the global library strategy and structures.
Leading a team of Global Library Programmers who create/update the standard data collection objects in the global library.
Leading the EDC system implementation to ensure adherence to best practices and promotion of effective use by GDM&CM.
This includes internal EDC module connections (e.
g.
, Safety Gateway, TSDV) and external system integrations (e.
g.
, with the Clinical Trial Management System and Payment systems).
Leading the collaboration with EDC providers and internal stakeholders to ensure the systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the providers' roadmap.
Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
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.
Contributing to the development and application of smart systems/tools and optimal approaches to support the collection of data with a standardized approach.
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 electronic data capture capability.
Authoring procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals.
Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.
Developing and conducting training and/or mentoring team members on key activities and processes.
Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause.
Ensuring timely closure of CAPA actions.
Representing the function for Health Authority inspections and internal audits.
Ensuring preparations and follow-up actions are being completed effectively by the team.
Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.
Ensuring effective quality oversight and management of external partners (e.
g.
Function Service Providers, CROs, technology providers, etc.
) performing activities on behalf of BMS.
Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
Representing BMS in interactions with key external partners as part of any committee or industry group relating to data collection.
For people managers:
Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes.
Managing the book of work, assigning resources to work 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.
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.
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.
Assigning resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion.
Requirements:
Bachelors degree required with an advanced degree preferredAt least 7 years of global clinical trial expertise with a focus on EDC global library development, management, and implementation.
Successful track record of leading through influence, working across complex, global organizational matrices, and effectively managing staff (for People Managers).
Deep understanding of the drug development process and clinical trial start-up/execution.
Proven expertise in EDC development, management, and implementation at the global level (not just at a study level).
Strong knowledge of industry leading EDC tools (e.
g.
, Medidata Rave, Oracle/Inform, etc.
) and well versed in industry trends and emerging technologies supporting data collection.
Strong knowledge of GCP/ICH guidelines, industry standard practices and good programming practices.
Significant experience with inspection readiness and CAPA development.
Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Strong stakeholder management and project management skills.
Excellent oral and written communication skills.
Demonstrated partnership across various collaborative and industry forums.
Diverse and deep 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 and develop colleagues.
#LI-HybridIf 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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
About the Company:
Bristol Myers Squibb.
Estimated Salary: $20 to $28 per hour based on qualifications.
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