SR.MANAGER, CLINICAL DATA MANAGEMENT

BioSpace; Redwood City (CA); Hybrid; USD 166,000 - 230,000; Full time

Benefits offered by this job

401(k) with company match

Comprehensive health plans

Employee Stock Purchase Plan

Job summary

A leading biotechnology company located in Redwood City is seeking a skilled Sr. Manager of Clinical Data Management. This role requires overseeing CRO activities and ensuring data quality in clinical trials. Candidates should have over 8 years of experience and a degree in Life Sciences. The position mandates onsite work at least three days a week, offering a competitive salary range of $166,000 to $230,000.

Qualifications

• 8+ years of experience in CDM within pharmaceutical/biotech industry.
• Deep expertise in Clinical Data Management processes and tools.
• Autoimmune or Oncology clinical trial experience is strongly preferred.

Responsibilities

• Oversee DM work performed by CROs.
• Review all DM related documents for accuracy and adherence to practices.
• Manage internal and CRO communications regarding data entry and quality.

Skills

Technical expertise in Data Management

Expertise in Microsoft Excel

Knowledge of CDISC Standards

Experience with EDC systems

Education

Bachelor's or Master's degree in Life Sciences

Tools

Medidata RAVE

Job description

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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.

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