Senior Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

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

Upload Resume

Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Lead and manage multiple clinical studies, ensuring data are collected, managed, and reported clearly, accurately, and securely • Conduct activities in conformance with regulatory requirements, industry guidelines, and company SOPs while meeting sponsor requirements and timelines • Serve as data management liaison to project teams, sponsors, and external vendors • Independently manage three to four concurrent studies with minimal supervision and make decisions with minimal managerial support • Attend sponsor meetings and answer data management questions • Provide timeline input and monitor scope of work for timely, within-budget completion • Develop eCRF specifications, including data capture screens and edit checks, for study-specific clinical databases/EDC systems • Program or assist with programming and maintain clinical databases • Validate and test clinical databases, including User Acceptance Testing • Develop eCRF completion guidelines and training materials; train site users and monitors • Develop data transfer agreements and specifications with external-data vendors • Reconcile external data with EDC data and sponsor safety databases when needed • Support development of external clinical-data systems such as ePRO and IWRS, documenting and testing data transfers • Develop data management plans and related documentation • Perform ongoing data review and cleaning through study conduct and database lock/close • Code medical terms in clinical databases as required • Generate data listings and reports for data review and database close/lock • Monitor study status and provide data status reports to project teams • Maintain complete, current data management documentation in the trial master file • Respond to EDC system users requiring assistance • Archive clinical databases and related documents • Participate in defining, writing, and updating data management Work Instructions • Mentor and train Clinical Data Coordinators and support less experienced Clinical Data Managers • Oversee outsourced activities and vendors to ensure timelines, deliverables, work orders, sponsor requirements, protocol requirements, and SOPs are met • Undertake other qualified responsibilities as assigned

🎯 Requirements

• B.Sc. in a related field of study • 5 to 8 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry • Understanding of the drug development process and applicable regulations, including Good Clinical Practices and ICH Guidelines • Extensive experience working with EDC systems and/or database structures • Demonstrated skills in database programming are an asset • Good understanding of CDISC SDTM/CDASH standards • Highly organized and detail-oriented with effective project planning and time management skills • Strong verbal and written communication skills in English; French is an asset • Good knowledge of MS Excel • Knowledge of SAS or similar is an asset • Excellent problem-solving abilities • Ability to work in a fast-paced environment and organize and prioritize multiple competing demands • Knowledge of MedDRA and WHODrug dictionaries • Must be legally able to work in Argentina • Attendance at some meetings outside regular business hours, primarily in the evening

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Stimulating work environment • Attractive advancement opportunities