Manager, Evidence Generation Data Management
Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion.
We are an equal opportunity employer including veterans and people with disabilities.
SummaryThe position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables Responsibilities - Study ResponsibilityResponsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close outEnsure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, - Database specifications, Database build, interim data cuts, Database lock and study archivingLeads the data review process in collaboration with the study team to ensure data qualityContribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.Must comply with international regulationsEnsure inspection readiness as well as prepare potential audits linked to assigned studies - Vendor OversightWith supervision, responsible for routine oversight of vendor delivery , to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Participates in drafting request for proposal for CRO selection.
Reviews base-line budget and timelines.
Contributes to budget management and activities across the project duration - Operational ExcellenceParticipate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutionsMaintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy - Any other duties deemed pertinent to the needs of the business Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university) - Bachelor's Degree Sciences preferred Experience Qualifications - 4 or More Years experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting and experience in oncology Therapeutic Area and/or in late phase projects required or - 7 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting and experience in oncology Therapeutic Area and/or in late phase projects, in lieu of Bachelor's Degree required Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Apply Now
We are an equal opportunity employer including veterans and people with disabilities.
SummaryThe position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables Responsibilities - Study ResponsibilityResponsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close outEnsure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, - Database specifications, Database build, interim data cuts, Database lock and study archivingLeads the data review process in collaboration with the study team to ensure data qualityContribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.Must comply with international regulationsEnsure inspection readiness as well as prepare potential audits linked to assigned studies - Vendor OversightWith supervision, responsible for routine oversight of vendor delivery , to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Participates in drafting request for proposal for CRO selection.
Reviews base-line budget and timelines.
Contributes to budget management and activities across the project duration - Operational ExcellenceParticipate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutionsMaintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy - Any other duties deemed pertinent to the needs of the business Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university) - Bachelor's Degree Sciences preferred Experience Qualifications - 4 or More Years experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting and experience in oncology Therapeutic Area and/or in late phase projects required or - 7 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting and experience in oncology Therapeutic Area and/or in late phase projects, in lieu of Bachelor's Degree required Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Apply Now