Clinovo
This range is provided by Clinovo. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $130,000.00/yr - $150,000.00/yr
Driving Talent Acquisition for Pharma, Biotech and Life Sciences | AI-Driven Clinical Research Staffing Expert Sponsor customer is seeking a Sr. CDM/Manager CDM for their team.
This position is required to work onsite at the office in Palo Alto, CA.
8+ years of CDM experience
Experience with study start-up and database lock required.
This role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands‑on experience and a collaborative mindset, working closely with cross‑functional teams to drive successful trial execution and regulatory submissions.
Responsibilities
Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
Coordinate with internal stakeholders, including Clinical Operations, Biostatistics, Regulatory Affairs, and IT, to ensure smooth data integration and reporting.
Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).
Education & Qualifications
Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
Experience managing study-level data management activities and working with external vendors.
Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
Demonstrated experience supporting regulatory submissions is a plus.
Strong problem‑solving, organizational, and communication skills.
Referrals increase your chances of interviewing at Clinovo by 2x
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Palo Alto, CA .
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Base pay range $130,000.00/yr - $150,000.00/yr
Driving Talent Acquisition for Pharma, Biotech and Life Sciences | AI-Driven Clinical Research Staffing Expert Sponsor customer is seeking a Sr. CDM/Manager CDM for their team.
This position is required to work onsite at the office in Palo Alto, CA.
8+ years of CDM experience
Experience with study start-up and database lock required.
This role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands‑on experience and a collaborative mindset, working closely with cross‑functional teams to drive successful trial execution and regulatory submissions.
Responsibilities
Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
Coordinate with internal stakeholders, including Clinical Operations, Biostatistics, Regulatory Affairs, and IT, to ensure smooth data integration and reporting.
Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).
Education & Qualifications
Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
Experience managing study-level data management activities and working with external vendors.
Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
Demonstrated experience supporting regulatory submissions is a plus.
Strong problem‑solving, organizational, and communication skills.
Referrals increase your chances of interviewing at Clinovo by 2x
Get notified about new Manager Clinical Data Management jobs in
Palo Alto, CA .
#J-18808-Ljbffr