Senior Clinical Data Manager

🔥 15 hours ago

🇨🇦 Canada – Remote

💵 $100k - $120k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.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.

Apply Now

Find Similar Remote Jobs

Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead clinical data management studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, and reduced timelines • Take accountability for all data management deliverables and provide direction and quality review for DM study teams • Ensure projects follow protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers, FSP Leads, and cross-functional leads to meet contracted milestones • Lead data-focused internal project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams • Identify risks and mitigations, communicate data-driven discussions, and support database lock dates • Monitor Biometrics deliverables, project progress, budgets, scope changes, and timeline impacts • Coordinate receipt and inventory of clinical and vendor data and ensure project completion documentation • Develop client relationships, review satisfaction surveys, implement action plans, and drive process improvements and team training • Track scope changes and obtain Sponsor approval • Provide leadership, mentorship, coaching, and technical guidance to DM staff • Support performance evaluations and career development of team members • Learn and evaluate new DM technologies and processes for improvement • Ensure service and quality meet DMP and scope-of-work specifications • Write, review, and update SOPs and associated documents • Maintain accurate work records • Reconcile clinical databases with safety, laboratory, and third-party data using local laboratory systems and batch data loads where appropriate • Represent DM/Biometrics in business opportunities and bid defense meetings • Attend and resolve client or internal audit issues • Promote Biometrics services to sponsors and perform other assigned duties

🎯 Requirements

• University / college degree • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • English speaking, writing, and reading required • 8 years of combined early or late-stage DM experience • Minimum 2 years of direct sponsor management experience • At least 2 years of technical mentoring experience • Experience handling customer negotiations • Experience managing Scope of Work and budgets • Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations • Proven ability to lead project strategies and department goals, objectives, and initiatives • Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotechnological companies • Time management skills and ability to adhere to project productivity metrics and timelines • Ability to work in a team environment and collaborate with peers • Ability to mentor junior department members and provide SME guidance on DM practices • Experience representing DM in bid defense meetings • Good organizational, communication, and interpersonal skills • Constructive problem-solving attitude while deadline focused • Preferred: university/college degree in life sciences, health sciences, information technology, or related subjects • Preferred: four or more years of Electronic Data Capture experience • Preferred: knowledge of Fortrea organization and SOPs

🏖️ Benefits

• Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay • Compensation considers skills, prior relevant experience, applicable degrees/certifications, internal equity, and market data

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume