What are the responsibilities and job description for the Senior Clinical Data Management Lead - San Diego, CA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. 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.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology, fibrosis and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO).
This Strategic Role Is Responsible For
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
Lead/provide the relevant support and input to continuous improvement activities within clinical data management
Provides support for CAPA implementation as required
Auto req ID
439390BR
Minimum Education Required
Bachelors
Job_Category
Management
Additional Qualifications/Responsibilities
Experience and Expertise Required
Bachelor’s Degree Required With An Advanced Degree Preferred.
At least 5 years of relevant industry experience.
Project management certification (e.g. PMP) is desirable.
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; Exhibits expertise 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 Requirements
5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
The starting compensation for this job is a range from $143,590– $168,930, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.
City*
San Diego
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. 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.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology, fibrosis and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO).
This Strategic Role Is Responsible For
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
Lead/provide the relevant support and input to continuous improvement activities within clinical data management
Provides support for CAPA implementation as required
Auto req ID
439390BR
Minimum Education Required
Bachelors
Job_Category
Management
Additional Qualifications/Responsibilities
Experience and Expertise Required
Bachelor’s Degree Required With An Advanced Degree Preferred.
At least 5 years of relevant industry experience.
Project management certification (e.g. PMP) is desirable.
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; Exhibits expertise 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 Requirements
5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
The starting compensation for this job is a range from $143,590– $168,930, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.
City*
San Diego
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
Salary : $143,590 - $168,930
