Associate, Clinical Data Management

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee and evaluate clinical and electronic Patient Reported Outcomes (ePRO) data, including video-based data collection.

• Create Data Management Plans, Case Report Form (CRF) Specifications, electronic CRFs (eCRFs), and relevant study documentation.

• Assist with data transfers, exports, migrations, and reconciliation processes.

• Engage in site initiation visits, user acceptance testing (UAT), and product rollouts.

• Work collaboratively with sponsors, sites, vendors, and interdisciplinary teams.

• Promote innovative strategies for remote data monitoring and patient-centric research methodologies.

• Facilitate the delivery and management of clinical and patient-reported data within Electronic Data Capture (EDC) platforms, including iTakeControl (iTC) technology.

• Support studies from initiation through to closure.

⛳️ Requirements

• Bachelor’s degree or equivalent professional background.

• Experience in supporting clinical study protocols, protocol amendments, observational studies, registries, data migrations, reporting, and data transfers.

• Professional experience in biopharma, pharmaceutical, Contract Research Organizations (CRO), clinical sites, or consulting environments.

• Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), FDA regulations, including 21 CFR Part 11, Annex 11, and Good Practice (GxP) processes.

• Knowledge of or experience with EDC, ePRO, Electronic Health Records (EHR), clinical research technologies, and health data collection systems.

• Proven ability to manage multiple projects, timelines, stakeholders, vendors, and study teams simultaneously.

• Excellent written and verbal communication skills.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Experience level ranging from 0–10 years is specified.

• Preferred: experience in digital health, digital therapeutics, or mobile applications.

• Preferred: experience in rare diseases, gene therapy, or long-term follow-up studies.

• Preferred: experience collaborating with central or specialty laboratories/vendors.

• Preferred: knowledge of CDISC, CDASH, SDTM, FHIR, OMOP, MedDRA, and WHO Drug standards and dictionaries.

🏝️ Benefits

• Commitment to an equal opportunity and inclusive workplace.

• No discrimination based on race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.