Chief Risk Officer Jobs in Newark
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Daiichi Sankyo, Inc.-Newark
under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides...
Daiichi Sankyo, Inc.-Newark
with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations...
Daiichi Sankyo, Inc.-Newark
and programmers at CROs. This position works under some supervision to solve complex study problems.
Responsibilities
• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation...
Daiichi Sankyo, Inc.-Newark
consultants (i.e. CRO's) as needed.
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...
Daiichi Sankyo, Inc.-Newark
specified product profile.
• CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers...
Newark
with in-house personnel, clinical sites and outside contractors/CROs.
• Develop and maintain professional relationships with key physicians, clinicians and principal investigators to assure good clinical input to Pacira Medical Device product development process...
pacira.com -
Daiichi Sankyo, Inc.-Newark
statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.
Responsibilities
• Protocol Development, Case Report...
Daiichi Sankyo, Inc.-Newark
Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with CROs, License Partners, and PV vendors. Provide PV oversight of the DSI Call Center. Provide oversight of ICSR processing activities including, Safety...
Daiichi Sankyo, Inc.-Newark
with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations...
Daiichi Sankyo, Inc.-Newark
programming tasks, including SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS...
Daiichi Sankyo, Inc.-Newark
with outside consultants (i.e. CRO’s) as needed.
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...
Daiichi Sankyo, Inc.-Newark
and activities related to systematic quality-related events specific to the external partner (CRO, co-sponsor, specialty vendor).
• Support the Business Partner Quality Lead(s) (BPQLs), who are responsible for delivering and executing Quality Oversight aspects...
Daiichi Sankyo, Inc.-Newark
collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal...
Daiichi Sankyo, Inc.-Newark
oversight to the CRO MM for clinical data review activities
• May support addressing eligibility and medical questions from sites/ IRBs
• May provide medical guidance for coding of AEs, medical history, and medications when needed
• Clinical Development...
Daiichi Sankyo, Inc.-Newark
Organization (CRO) Medical Monitor (MM):
• Provides oversight to the CRO MM for clinical data review activities
• May support addressing eligibility and medical questions from sites/ IRBs
• May provide medical guidance for coding of AEs, medical history...
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