BioSpace
SR.MANAGER, CLINICAL DATA MANAGEMENT
BioSpace, Redwood City, California, United States, 94061
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SR.MANAGER, CLINICAL DATA MANAGEMENT
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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com. JOIN US!
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Sr. MANAGER, CLINICAL DATA MANAGEMENT
Adicet Bio is seeking a highly skilled and experienced hands-on Sr. Manager of Clinical Data Management (CDM) who will be responsible for providing technical expertise and overseeing DM work performed by CROs. The Sr. Manager CDM is expected to have extensive experience in Data Management from DM Study Starup through Database Lock and Archiving.
Responsibilities Will Include
Review of all DM related documents for completeness, technical accuracy and adherence to DM current best practices. These include CCGs, DMPs, DVSs, DRPs, Coding Guidelines, DTSs, etc. Knowledge of CDISC Standard including CDASH for eCRF Development and CDISC current Codelists for eCRFs Expertise in working with Microsoft Excel. Ability to download Reports from Medidata RAVE to create summary reports for Study Teams using filters, sorts, pivot Tables and graphical displays of outliers and data inconsistencies. Experience with downloading and reviewing raw eCRF data from Medidata RAVE as part of oversight. Development and finalization of Data Transfer Specifications (DTSs) with external vendors for central Lab data, Imaging Data, Biomarkers, etc. Knowledge of EDC systems including Medidata RAVE with experience on EDC Setup, UAT, ALS, Custom Functions, Coding, PD Module, Standard and custom reports on quality and timeliness of DM tasks, etc. Oversight and management of CROs including managing timelines and effective communications. Providing feedback to internal and CRO team members for accountability and building high performance teams. Internal communication and collaboration with study teams and Sr. Management for DM activities. Review and provide to internal teams, DM performance and aging reports on data entry completion, missing pages, query resolution, clean patients, etc. Follow-up with CROs, ClinOps, CRAs and CRCs as needed to avoid backlog and meet internal analysis requirements. Generate Agendas, Minutes and Action Items for internal meetings. Experience with Development of internal Work Instructions, Templates, SOPs, Checklists as needed Experience with CAR-T, Oncology, Auto-immune diseases a plus Experience with Master Protocols a plus Experience with EDC Builds including custom function programming a plus Knowledge of CDISC SDTM and ADaM including TAUG’s a plus Knowledge of GCDM Practices a plus Familiarity with 21CFR Part 11, 50, 54 312, 314; applicable FDA Guidelines including 2024 guideline on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations a plus Familiarity with ICH E3R1, E5R1, E6R3, E8R1, E9, E9R1, E14, E17, E19 a plus
Qualifications:
Bachelors or Masters degree in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields 8+ years of experience in CDM within pharmaceutical/biotechnology industry from study setup, conduct through database lock for Phase 2 or 3 studies. Deep expertise in CDM and associated technologies, processes and tools. Understanding of regulations and guidelines including ICH E6 GCPs, CDASH, CDISC as applicable to CDM Autoimmune or Oncology clinical trial experience is strongly preferred
Pay Range$166,000—$230,000 USD
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday–Thursday mandatory) , with some roles requiring full-time onsite presence.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.
We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.
To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.
We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Manager Clinical Data Management” roles.
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SR.MANAGER, CLINICAL DATA MANAGEMENT
role at
BioSpace 2 days ago Be among the first 25 applicants Join to apply for the
SR.MANAGER, CLINICAL DATA MANAGEMENT
role at
BioSpace Get AI-powered advice on this job and more exclusive features. JOIN US!
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com. JOIN US!
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Sr. MANAGER, CLINICAL DATA MANAGEMENT
Adicet Bio is seeking a highly skilled and experienced hands-on Sr. Manager of Clinical Data Management (CDM) who will be responsible for providing technical expertise and overseeing DM work performed by CROs. The Sr. Manager CDM is expected to have extensive experience in Data Management from DM Study Starup through Database Lock and Archiving.
Responsibilities Will Include
Review of all DM related documents for completeness, technical accuracy and adherence to DM current best practices. These include CCGs, DMPs, DVSs, DRPs, Coding Guidelines, DTSs, etc. Knowledge of CDISC Standard including CDASH for eCRF Development and CDISC current Codelists for eCRFs Expertise in working with Microsoft Excel. Ability to download Reports from Medidata RAVE to create summary reports for Study Teams using filters, sorts, pivot Tables and graphical displays of outliers and data inconsistencies. Experience with downloading and reviewing raw eCRF data from Medidata RAVE as part of oversight. Development and finalization of Data Transfer Specifications (DTSs) with external vendors for central Lab data, Imaging Data, Biomarkers, etc. Knowledge of EDC systems including Medidata RAVE with experience on EDC Setup, UAT, ALS, Custom Functions, Coding, PD Module, Standard and custom reports on quality and timeliness of DM tasks, etc. Oversight and management of CROs including managing timelines and effective communications. Providing feedback to internal and CRO team members for accountability and building high performance teams. Internal communication and collaboration with study teams and Sr. Management for DM activities. Review and provide to internal teams, DM performance and aging reports on data entry completion, missing pages, query resolution, clean patients, etc. Follow-up with CROs, ClinOps, CRAs and CRCs as needed to avoid backlog and meet internal analysis requirements. Generate Agendas, Minutes and Action Items for internal meetings. Experience with Development of internal Work Instructions, Templates, SOPs, Checklists as needed Experience with CAR-T, Oncology, Auto-immune diseases a plus Experience with Master Protocols a plus Experience with EDC Builds including custom function programming a plus Knowledge of CDISC SDTM and ADaM including TAUG’s a plus Knowledge of GCDM Practices a plus Familiarity with 21CFR Part 11, 50, 54 312, 314; applicable FDA Guidelines including 2024 guideline on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations a plus Familiarity with ICH E3R1, E5R1, E6R3, E8R1, E9, E9R1, E14, E17, E19 a plus
Qualifications:
Bachelors or Masters degree in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields 8+ years of experience in CDM within pharmaceutical/biotechnology industry from study setup, conduct through database lock for Phase 2 or 3 studies. Deep expertise in CDM and associated technologies, processes and tools. Understanding of regulations and guidelines including ICH E6 GCPs, CDASH, CDISC as applicable to CDM Autoimmune or Oncology clinical trial experience is strongly preferred
Pay Range$166,000—$230,000 USD
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite
at least three days per week (Tuesday–Thursday mandatory) , with some roles requiring full-time onsite presence.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.
We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.
To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.
We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Manager Clinical Data Management” roles.
Alameda, CA $190,000.00-$240,000.00 1 week ago Biosample Operations Senior Associate / Manager
South San Francisco, CA $100,000.00-$144,000.00 3 days ago Associate Director, Clinical Data Management
Senior Director, Clinical Data Management
Redwood City, CA $265,000.00-$295,000.00 2 weeks ago Senior Director, Clinical Data Management
San Francisco, CA $250,000.00-$275,000.00 2 days ago Director/Senior Director, Clinical Data Management
Associate Director, Clinical Data Management
Engineering Manager - AI/Data, Mid-Level
South San Francisco, CA $172,000.00-$191,000.00 2 weeks ago Menlo Park, CA $135,000.00-$155,000.00 2 weeks ago San Francisco Bay Area $116,000.00-$145,000.00 2 weeks ago Redwood City, CA $166,000.00-$230,000.00 4 days ago San Jose, CA $70,000.00-$75,000.00 3 weeks ago Alameda, CA $86,700.00-$173,300.00 5 days ago Alameda, CA $86,700.00-$173,300.00 5 days ago San Mateo County, CA $80.00-$90.00 1 week ago Redwood City, CA $165,000.00-$200,000.00 2 weeks ago Clinical Trial Manager/Senior Clinical Trial Manager
San Francisco, CA $150,000.00-$190,000.00 3 days ago San Francisco, CA $145,000.00-$180,000.00 2 weeks ago Senior Clinical Trial Manager (Contract)
Senior Manager, Clinical Data Management
Redwood City, CA $180,000.00-$195,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr