Clinical Data Manager/Sr. Clinical Data Manager (Onsite/Remote)

Job Type Full-time Description

The Clinical Data Manager/Sr. Clinical Data Manager will support our clinical trials by designing, building, implementing and maintaining electronic data capture (EDC) systems. This role requires expertise in clinical data management and visualization and proficiency in biostatistics. The ideal candidate will be skilled in data visualization software and capable of managing data collection processes to ensure high-quality clinical data while contributing to regulatory submissions and cross-functional decision-making.

As a pre-commercial company, we require someone who thrives in a dynamic environment, where they will be responsible for building systems from the ground up rather than refining existing ones. The ability to design scalable data solutions, integrate data from multiple platforms, and adapt to evolving business needs is essential. Experience with customer relationship management (CRM) systems is valuable, as is familiarity with Real-World Data (RWD) sources such as claims databases, electronic health records (EHRs), and registries.

Location: Onsite-Sunnyvale, California or Remote

Requirements

Essential duties and responsibilities include, but are not limited to, the following: 

  

Clinical Database & Data Management:

• Develop, implement, and maintain EDC systems for clinical trials.
• Design and validate CRFs (case report forms), ensuring compliance with industry standards.
• Oversee and perform database setup, validation, and user acceptance testing.
• Implement risk-based monitoring (RBM) methodologies to enhance data oversight.

Data Integrity & Quality Assurance:

• Monitor data collection, enforce quality controls, and develop data management plans.
• Ensure data compliance with CDISC, SDTM, and CDASH standards for regulatory submissions.
• Collaborate with clinical operations, biostatistics, and regulatory teams to maintain data integrity.

Analytical & Statistical Expertise:

• Partner with biostatisticians on statistical analysis      and clinical study report development.
• Provide insights from clinical data to drive study      outcomes and business decisions.

Data Reporting & Visualization:

• Develop interactive dashboards and visualizations using Power BI or similar tools.
• Deliver ad-hoc data analyses for regulatory submissions, publications, and internal use.

Regulatory & Compliance Support:

• Ensure compliance with FDA, EMA, GCP, and PMDA data regulations.
• Support audits and regulatory inspections related to clinical data integrity.
• Contribute to regulatory submissions by ensuring high-quality data outputs.

Vendor & Contract Research Organization (CRO) Management:

• Oversee data-related interactions with CROs and external vendors.
• Ensure outsourced activities align with regulatory requirements and internal data standards.

Cross-Functional Collaboration:

• Work closely with clinical, regulatory, and commercial teams to integrate data insights.
• Provide leadership in designing scalable clinical data management solutions.
• Train and guide internal teams on best practices in data collection and analysis.

Qualifications:

Education & Experience:     

• Bachelor’s degree in life sciences, biostatistics, computer sciences, or a related field is required. Advanced   degree in life sciences, biostatistics, computer sciences or a related field is a plus.
• Minimum of 5+ years (Manager) or 7+ years (Senior Manager) in clinical data management.
• Hands-on experience with EDC systems (Medidata Rave, Veeva Vault, REDCap, or similar).
• Experience with CRM systems and RWD sources is highly desirable.
• Medical device experience is preferred.

Knowledge, Skills, and Abilities: 

• Strong understanding of clinical trial data flow and regulatory requirements.
• Demonstrated knowledge and deep understanding   of regulations and industry-adopted data standards such as CDISC, SDTM, and CDASH.
• Demonstrated knowledge and deep understanding of regulatory standards, including  FDA,   EMA, GCP, and PMDA guidelines, and how they apply to clinical data management.
• Ability to perform data validation, cleaning, and query resolution.
• Strong analytical and problem-solving skills.
• Ability to work independently in an evolving environment.
• Excellent communication skills to facilitate cross-functional collaboration.
• Detail-oriented with a focus on data accurac