Associate Manager, Clinical Data Management

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $85k - $95k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Lead data management activities on clinical studies from study start-up through database lock • Take responsibility for project documentation, system setup, data entry, and data validation procedures • Work directly with Sponsors to understand and implement requirements • Lead studies involving healthy volunteer and patient populations, multi-site studies, client management, or reduced timelines • Organize and prioritize workload and deliverables • Own DM deliverables, instruct study teams, review outputs, and adjust resource allocations • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build project timelines with Project Managers to meet contracted milestones • Lead data-focused internal project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK • Identify risks and mitigations, communicate data-driven discussions, and support database lock dates • Keep Project Managers, Biometrics management, and sponsor services informed of project progress, budgets, scope changes, and timeline impacts • Develop client relationships and review client satisfaction surveys • Track scope changes and obtain Sponsor approval • Provide leadership, mentorship, coaching, and constructive feedback to study team members • Learn and apply new DM technologies and processes for improvement • Maintain accurate work records • Reconcile clinical databases against safety, laboratory, and third-party data • Utilize local laboratory systems and batch data load facilities where appropriate • Represent Data Management and Biometrics in new business opportunities • Attend and action client or internal audits and resolve issues • Address client comments with the study team • Promote Biometrics services to sponsors • Perform other duties as assigned

🎯 Requirements

• University / college degree; relevant and equivalent experience may be considered in lieu of educational requirements • Experience and/or education plus relevant work experience equating to a bachelor's degree accepted in lieu of a bachelor’s degree • Fluent in English, both written and verbal • Approximately 3 years in a primary data management role in complex in-house studies, or 5+ years supporting hands-on data review and reconciliation • 6 to 8 years of DM experience with minimum of 1 year of direct sponsor management • Experience in in-house study start-up, conduct, and closeout • Create/update Data Management Plan, eCRF Completion Guidelines, Data Review Plan, SAE Reconciliation Plan and Edit Check Specifications • Perform UAT of the EDC database and data validation listings • Proficient in complex external data reconciliation including eCOA, PK, local lab ranges, Biomarkers, etc. • Perform EDC data cleaning • Raise queries in EDC based on monthly cross functional data review findings • Maintain issue log • Upload documents to eTMF • Perform metrics reporting at team meetings • Protocol deviation reconciliation experience • Experience with database lock tasks • Strong communication skills • Ability to work on fast-paced studies • Knowledge of clinical trial process, data management, clinical operations, biometrics, and system applications • Time management and ability to adhere to project productivity metrics and timelines • Knowledge of medical terminology • 3+ years of Electronic Data Capture experience • Prior Veeva EDC experience is a plus • Life sciences, health sciences, information technology or related degree preferred • Knowledge of science or a scientific background preferred • Thorough knowledge of Fortrea organization and SOPs preferred • May require overtime and weekend work • Willingness to work flexible shifts as required

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • STD/LTD • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable • Flexible shifts as per business requirement • Office and home-based work environment