Bristol-Myers Squibb
Senior Manager, Clinical Data Management
Bristol-Myers Squibb, Princeton, New Jersey, us, 08543
Senior Manager, Clinical Data Management
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.Job Title:
Senior Manager, Clinical Data Management (ref.# 4488)Job Location:
3551 Lawrenceville Road, Princeton, NJ 08540Duties:
Provide 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 plan, coordinate, and deliver 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. Provide strong quality and project oversight over third party vendor responsible for data management deliverables. Take 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). Enforce data standard conventions and quality expectations for clinical data per defined processes. Author, review/revise data management 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 on-going review of trial data currency, quality and completeness. Represent data management on cross-functional project teams and submission Teams. Lead or support the Health Authority inspections and audits. Provide coaching and quality oversight of junior data management leads. May act as core member of the study team and provides FSP/clinical research organization/vendor oversight for end-to-end data management activities, manages data currency throughout the trial, and overall monitoring data management deliverables according to the Service Level Agreement. Provide the relevant support and input to continuous improvement activities within clinical data management. Provide support for corrective and preventive actions implementation.Requirements:
Master’s degree (or foreign equivalent) in information systems technology – information assurance, information systems technology or a related field plus 5 years of post-baccalaureate experience. Experience must include: Rave EDC, JReview, data management end-to-end process knowledge, Spotfire, Veeva Vault, and project management. The required skills do not need to be maintained over the full term of required experience to reflect demonstrable ability in the skill set described above.Contact:
Althea WilsonBristol-Myers Squibb Company4931 George RoadTampa, FL 33634Resume.com@bms.comCompensation:
The starting compensation for this job is a range from $161,470 to $188,606, 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.Additional Information:
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.
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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.Job Title:
Senior Manager, Clinical Data Management (ref.# 4488)Job Location:
3551 Lawrenceville Road, Princeton, NJ 08540Duties:
Provide 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 plan, coordinate, and deliver 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. Provide strong quality and project oversight over third party vendor responsible for data management deliverables. Take 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). Enforce data standard conventions and quality expectations for clinical data per defined processes. Author, review/revise data management 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 on-going review of trial data currency, quality and completeness. Represent data management on cross-functional project teams and submission Teams. Lead or support the Health Authority inspections and audits. Provide coaching and quality oversight of junior data management leads. May act as core member of the study team and provides FSP/clinical research organization/vendor oversight for end-to-end data management activities, manages data currency throughout the trial, and overall monitoring data management deliverables according to the Service Level Agreement. Provide the relevant support and input to continuous improvement activities within clinical data management. Provide support for corrective and preventive actions implementation.Requirements:
Master’s degree (or foreign equivalent) in information systems technology – information assurance, information systems technology or a related field plus 5 years of post-baccalaureate experience. Experience must include: Rave EDC, JReview, data management end-to-end process knowledge, Spotfire, Veeva Vault, and project management. The required skills do not need to be maintained over the full term of required experience to reflect demonstrable ability in the skill set described above.Contact:
Althea WilsonBristol-Myers Squibb Company4931 George RoadTampa, FL 33634Resume.com@bms.comCompensation:
The starting compensation for this job is a range from $161,470 to $188,606, 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.Additional Information:
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.
#J-18808-Ljbffr