Senior Manager, Clinical Data Management
Bristol-Myers Squibb
Senior Manager, Clinical Data Management
Job Description
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 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) Provides the relevant support and input to continuous improvement activities within clinical data management Provides support for CAPA implementation as 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)]
Key Responsibilities
- Provide clinical data management leadership within the study team to align on and drive data collection requirements for complex clinical development projects
- Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Be responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members
- Provide strong quality and project oversight over third party vendor responsible for data management deliverables
- Gather content and integration requirements for EDC and collaborate closely with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforce data standard conventions and quality expectations for clinical data per defined processes
- Author, review, and revise 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
- Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness
- Represent DM on cross-functional project teams and submission teams
- Lead or support Health Authority inspections and audits
- Provide coaching and quality oversight of junior Data Management Leads
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA)
- Provide relevant support and input to continuous improvement activities within clinical data management
- Support CAPA implementation as required
Required Qualifications
- Bachelor's Degree required
- At least 5 years of relevant industry experience
Preferred Qualifications
- Advanced degree preferred
- Project management certification (e.g. PMP) desirable
Skills Required
- 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
- Well versed in industry trends and emerging technologies supporting data collection
- Strong project management skills
- Expertise in metrics analysis and reporting methodologies
- Excellent oral and written communication skills
- Ability to 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)
Locations
- Warsaw, PL
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 PLN / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendorsintermediate
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data managementintermediate
- Strong knowledge and experience of EDC systems (Medidata RAVE preferred)intermediate
- Demonstrated knowledge of Microsoft Office skillsintermediate
- Well versed in industry trends and emerging technologies supporting data collectionintermediate
- Strong project management skillsintermediate
- Expertise in metrics analysis and reporting methodologiesintermediate
- Excellent oral and written communication skillsintermediate
- Ability to communicate effectively with senior management and cross-functional teamsintermediate
- Knowledge of submission requirements, e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)intermediate
Required Qualifications
- Bachelor's Degree required (experience)
- At least 5 years of relevant industry experience (experience)
Preferred Qualifications
- Advanced degree preferred (experience)
- Project management certification (e.g. PMP) desirable (experience)
Responsibilities
- Provide clinical data management leadership within the study team to align on and drive data collection requirements for complex clinical development projects
- Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Be responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members
- Provide strong quality and project oversight over third party vendor responsible for data management deliverables
- Gather content and integration requirements for EDC and collaborate closely with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforce data standard conventions and quality expectations for clinical data per defined processes
- Author, review, and revise 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
- Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness
- Represent DM on cross-functional project teams and submission teams
- Lead or support Health Authority inspections and audits
- Provide coaching and quality oversight of junior Data Management Leads
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA)
- Provide relevant support and input to continuous improvement activities within clinical data management
- Support CAPA implementation as required
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Senior Manager, Clinical Data Management
Bristol-Myers Squibb
Senior Manager, Clinical Data Management
Job Description
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 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) Provides the relevant support and input to continuous improvement activities within clinical data management Provides support for CAPA implementation as 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)]
Key Responsibilities
- Provide clinical data management leadership within the study team to align on and drive data collection requirements for complex clinical development projects
- Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Be responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members
- Provide strong quality and project oversight over third party vendor responsible for data management deliverables
- Gather content and integration requirements for EDC and collaborate closely with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforce data standard conventions and quality expectations for clinical data per defined processes
- Author, review, and revise 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
- Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness
- Represent DM on cross-functional project teams and submission teams
- Lead or support Health Authority inspections and audits
- Provide coaching and quality oversight of junior Data Management Leads
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA)
- Provide relevant support and input to continuous improvement activities within clinical data management
- Support CAPA implementation as required
Required Qualifications
- Bachelor's Degree required
- At least 5 years of relevant industry experience
Preferred Qualifications
- Advanced degree preferred
- Project management certification (e.g. PMP) desirable
Skills Required
- 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
- Well versed in industry trends and emerging technologies supporting data collection
- Strong project management skills
- Expertise in metrics analysis and reporting methodologies
- Excellent oral and written communication skills
- Ability to 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)
Locations
- Warsaw, PL
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 PLN / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendorsintermediate
- Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data managementintermediate
- Strong knowledge and experience of EDC systems (Medidata RAVE preferred)intermediate
- Demonstrated knowledge of Microsoft Office skillsintermediate
- Well versed in industry trends and emerging technologies supporting data collectionintermediate
- Strong project management skillsintermediate
- Expertise in metrics analysis and reporting methodologiesintermediate
- Excellent oral and written communication skillsintermediate
- Ability to communicate effectively with senior management and cross-functional teamsintermediate
- Knowledge of submission requirements, e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)intermediate
Required Qualifications
- Bachelor's Degree required (experience)
- At least 5 years of relevant industry experience (experience)
Preferred Qualifications
- Advanced degree preferred (experience)
- Project management certification (e.g. PMP) desirable (experience)
Responsibilities
- Provide clinical data management leadership within the study team to align on and drive data collection requirements for complex clinical development projects
- Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Be responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members
- Provide strong quality and project oversight over third party vendor responsible for data management deliverables
- Gather content and integration requirements for EDC and collaborate closely with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
- Enforce data standard conventions and quality expectations for clinical data per defined processes
- Author, review, and revise 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
- Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness
- Represent DM on cross-functional project teams and submission teams
- Lead or support Health Authority inspections and audits
- Provide coaching and quality oversight of junior Data Management Leads
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA)
- Provide relevant support and input to continuous improvement activities within clinical data management
- Support CAPA implementation as required
Tags & Categories
Answer 10 quick questions to check your fit for Senior Manager, Clinical Data Management @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs