![Bristol Myers Squibb](https://media.trabajo.org/img/noimg.jpg)
Senior Manager, Clinical Data Management
4 weeks ago
Description
Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock.
Position Summary / Objective
The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management
This is anoffice-based in BMS New Jersey, San Diego, Seattle or Boudry (Switzerland) offices
Responsibilities will include, but are not limited to:
Project Management and Leadership
•Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
•Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
•Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
•Provides strong quality and project oversight over third party vendor responsible for data management deliverables
•Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
•Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
•Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency ,quality and completeness
•Represents DM on cross-functional project teams & submission Teams
•Lead or support the Health Authority inspections and audits
•Provides coaching and quality oversight of junior Data Management Leads
FSP/CRO/Vendor Oversight
May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Continuous improvement initiatives
Provides the relevant support and input to continuous improvement activities within clinical data management
Provides support for CAPA implementation as required
Degree Requirements
Bachelor’s Degree requiredwith an advanced degree preferred
Experience Requirements
At least 5 years of relevant industry experience.
Project management certification (e.g. PMP) is desirable
Key Competency Requirements
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
Strong project management;Exhibitsexpertise in metrics analysis and reporting methodologies
Excellent oral and written communication skills
Communicate effectively with senior management and cross-functional teams
Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Travel Required
Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections
(as needed)
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work
Environment
NA
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 . Visit 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.
-
Manager, Clinical Data Management
1 week ago
San Diego, United States Therapeutics Inc. Full time**Who Are We?** Founded in 1997 and built upon 26+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent....
-
Senior Clinical Data Manager Contractor
2 months ago
South San Francisco, United States Bayside Solutions, Inc. Full timeSenior Clinical Data Manager Contractor The Opportunity (6 month contract/eligible for renewal and potential conversion) In anticipation of the Company' s growth plans, seeking to recruit a Senior Clinical Data Manager Contractor. The Senior Clinical Data, Clinical, Senior, Manager, Clinic, Management, Staffing, Technology
-
Senior Clinical Data Manager Contractor
4 weeks ago
South San Francisco, United States Bayside Solutions, Inc. Full timeSenior Clinical Data Manager Contractor The Opportunity (6 month contract/eligible for renewal and potential conversion) In anticipation of the Company' s growth plans, seeking to recruit a Senior Clinical Data Manager Contractor. The Senior Clinical Data, Clinical, Senior, Manager, Clinic, Management, Staffing, Technology
-
Senior Clinical Data Manager
4 weeks ago
South San Francisco, United States Meet Full timeJob Title: Senior Manager, Clinical Data Management Position Summary:We are seeking a dedicated and detail-oriented Clinical Data Manager to join our team. The Clinical Data Manager will play a critical role in ensuring the accuracy, quality, and integrity of clinical trial data. This position requires collaboration with various departments and external...
-
Senior Clinical Data Manager
4 weeks ago
South San Francisco, United States Meet Full timeJob Title: Senior Manager, Clinical Data Management Position Summary:We are seeking a dedicated and detail-oriented Clinical Data Manager to join our team. The Clinical Data Manager will play a critical role in ensuring the accuracy, quality, and integrity of clinical trial data. This position requires collaboration with various departments and external...
-
Senior Clinical Data Manager
4 weeks ago
South San Francisco, United States Meet Full timeJob Title: Senior Manager, Clinical Data Management Position Summary:We are seeking a dedicated and detail-oriented Clinical Data Manager to join our team. The Clinical Data Manager will play a critical role in ensuring the accuracy, quality, and integrity of clinical trial data. This position requires collaboration with various departments and external...
-
Senior Clinical Data Manager
3 weeks ago
South San Francisco, United States Meet Full timeJob Title: Senior Manager, Clinical Data Management Position Summary:We are seeking a dedicated and detail-oriented Clinical Data Manager to join our team. The Clinical Data Manager will play a critical role in ensuring the accuracy, quality, and integrity of clinical trial data. This position requires collaboration with various departments and external...
-
Part-time Clinical Research Data Developer
5 days ago
San Diego, United States Axiom Resource Management, Inc. Full timeWe are seeking a **Part-Time Clinical Research Data Developer/Manager **to support a health organization in San Diego, CA. - Manage all aspects of clinical database design and reporting. - Establish and maintain policies and procedures for gathering, analyzing, and reporting clinical data. - Standardize data management procedures and documents departmental...
-
Senior Clinical Study Manager
1 month ago
San Diego, United States BioSpace Full timeJob DetailsPosition Summary This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support of AnaptysBio product development portfolio. The Senior Clinical Study Manager (Sr. CSM) will independently organize and manage multiple activities related to clinical...
-
Senior Clinical Study Manager
4 weeks ago
San Diego, United States BioSpace Full timeJob DetailsPosition Summary This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support of AnaptysBio product development portfolio. The Senior Clinical Study Manager (Sr. CSM) will independently organize and manage multiple activities related to clinical...
-
Senior Clinical Trial Manager
4 weeks ago
San Diego, United States BioPhase Full timeMust be located in San Diego, CA | willing to work onsiteThe Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating...
-
Senior Clinical Trial Manager
3 weeks ago
San Diego, United States BioPhase Full timeMust be located in San Diego, CA | willing to work onsiteThe Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating...
-
Senior Clinical Trial Manager
5 days ago
San Diego, United States BioPhase Full timeMust be located in San Diego, CA | willing to work onsite The Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating...
-
Associate Director, Clinical Data Management
1 month ago
San Diego, United States BioSpace Full timeJob DetailsJob Type Full-time The Associate Director, Clinical Data Management will be responsible for supporting data management activities in phase 1 - 4 clinical trials. The incumbent will oversee outsourced studies ensuring appropriate interpretation and translation of the study protocol into validated data collection applications, tools, and systems...
-
Associate Director, Clinical Data Management
4 weeks ago
San Diego, United States BioSpace Full timeJob DetailsJob Type Full-time The Associate Director, Clinical Data Management will be responsible for supporting data management activities in phase 1 - 4 clinical trials. The incumbent will oversee outsourced studies ensuring appropriate interpretation and translation of the study protocol into validated data collection applications, tools, and systems...
-
Senior Clinical Data Analytics
2 months ago
San Diego, United States Integrated Resources, Inc Full timeThe Clinical Data Analytics Associate is responsible for programming and testing clinical trial data reports/listings, dashboards and analytics. This requires an in depth understanding of data programming, testing, data technology, data flow, and data standards. The Clinical Data Analytics Associate collaborates with the Clinical Data Management...
-
Senior Clinical Data Analytics
4 weeks ago
San Diego, United States Integrated Resources, Inc Full timeThe Clinical Data Analytics Associate is responsible for programming and testing clinical trial data reports/listings, dashboards and analytics. This requires an in depth understanding of data programming, testing, data technology, data flow, and data standards. The Clinical Data Analytics Associate collaborates with the Clinical Data Management...
-
Senior Clinical Data Analytics
1 week ago
San Diego, California, United States Integrated Resources Full timeThe Clinical Data Analytics Associate is responsible for programming and testing clinical trial data reports/listings, dashboards and analyticsThis requires an in depth understanding of data programming, testing, data technology, data flow, and data standardsThe Clinical Data Analytics Associate collaborates with the Clinical Data Management Associate,...
-
Senior Clinical Trial Manager
1 month ago
San Diego, United States The Scripps Research Institute Full timePOSITION TITLE: Senior Clinical Trial Manager ABOUT US Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated...
-
Senior Clinical Trial Manager
4 weeks ago
San Diego, United States The Scripps Research Institute Full timePOSITION TITLE: Senior Clinical Trial Manager ABOUT US Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated...