Clinical Data Manager

Clinical Data Manager - Electronic Data Capture (EDC)

ClinCapture is revolutionizing the clinical trial industry with its Captivate® eSource Platform and eClinical products including Electronic Data Capture (EDC) for traditional trials and Virtual Data Capture® (VDC®), a leading-edge suite of products designed to expedite remote and decentralized clinical trials. ClinCapture’s eClinical products enable sponsors and CROs to rapidly build and deploy studies, lower clinical trial costs, and streamline data capture processes. ClinCapture’s technologies help advance the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/ or treatment of a wide range of diseases or medical conditions. For more information, please visit clincapture.com and follow ClinCapture on LinkedIn.

This role hybrid (in office/WFH) in San Francisco, CA. *Candidates must be located in the San Francisco Bay Area

ClinCapture is looking for a Clinical Data Manager (CDM) to be a subject matter expert in ClinCapture's Captivate® eClinical suite. You will work within the Electronic Data Capture system to provide professional service deliverables such as eCRF design, data management plans/guidelines, and database configuration to customers in accordance with industry regulations and best practices. You will work with internal teams and communicate with customers to ensure high quality clinical trial data is delivered and customer milestones are met. As a CDM at ClinCapture, you will work directly with customers to identify professional services business expansion opportunities to ensure customers have a positive experience with the software.

Job Responsibilities:

• Act as the primary contact for all data management-related inquiries from customers and internal teams
• Manage assigned projects and ensure deliverables are on-time
• Own all data management aspects for assigned projects from start-up to completion, including database modifications post go-live
• Develop data management plans and guidelines to ensure high-quality clinical data
• Design and configure electronic case report forms (eCRFs) and all associated documentation, including completion guidelines and instructions
• Participate in User Acceptance Testing (UAT) and create and maintain data validation specifications
• Communicate with customers to provide regular status updates to ensure timely delivery
• Foster strong relationships with customers to ensure all of their questions are addressed and their goals are met
• Execute all data management activities in compliance with internal SOPs, industry regulations, and GCP standards
• Work cross-functionally between departments to answer customer questions including RFIs and RFPs
• Identify opportunities for expanding professional services to enhance customer satisfaction and drive business growth

Skills:

• Highly experienced working in Electronic Data Capture systems
• In-depth understanding of database structures and clinical workflows
• Experienced in database programming and eCRF configuration
• Knowledge of clinical data standards such as CDISC CDASH/SDTM
• Familiarity with GCP, ICH, and GCDMP
• Understanding of FDA 21 CFR Part 11, HIPAA, GDPR, Annex 11
• Familiarity with coding dictionaries such as WHODrug, MedDRA, CTCAE, ICD
• Comfortability working in a customer-facing role and communicating regularly with customers

Requirements (must have):

• Bachelor's degree in a related field (e.g. Life Sciences, Data Science, Computer Science, etc.)
• 5+ years of clinical data management experience at a pharmaceutical, biotech, medical device, or diagnostics company or contract research organization (CRO)

Requirements (nice to have):

• Master's degree in a related field
• Knowledge of programming languages such as JavaScript

Compensation:

• Base Salary Range $90,000 - $120,000 depending on experience and qualifications
• Performance-based bonus opportunities
• Benefits: Health insurance (Medical, Dental, Vision), 401(k) with 5% company matching, life insurance, Paid Time Off (PTO), paid holidays, stock options, and Equinox gym membership