Senior Clinical Data Manager – FSP

🔥 2 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead large clinical studies or a series of related studies with minimal guidance • Represent Data Management on cross-functional clinical trial working groups • Oversee and monitor data management activities performed by CROs and external vendors • Review clinical protocols and provide leadership on data capture strategy, eCRF design, and data collection requirements • Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to develop annotated eCRFs and completion guidelines • Lead development of data edit check specifications, data listings, and study-level data management plans • Coordinate the design, testing, and implementation of Electronic Data Capture systems and resolve system-related issues • Review and provide feedback on study documentation, including monitoring plans, statistical analysis plans, and vendor specifications • Conduct data reconciliations, including Serious Adverse Event and external data source reconciliation • Lead database upgrades, migrations, user acceptance testing, database freeze activities, and database locks • Maintain study workbooks, data management files, and study documentation • Mentor and train data management team members • Contribute to SOPs, work instructions, and process improvements • Participate in team meetings and contribute expertise supporting study and organizational objectives

🎯 Requirements

• BA/BS degree, preferably in a scientific or healthcare-related field • At least five years of experience in Data Management within the pharmaceutical or biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience • Knowledge of ICH-GCP, FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial processes • Experience with Electronic Data Capture systems and clinical data management technologies • Strong project management, organization, communication, problem-solving, and multitasking skills • Proven ability to support Phase 1-4 clinical studies and work effectively with vendors and cross-functional teams • Familiarity with database upgrades, migrations, user acceptance testing, and advanced data management processes • Strong English written and verbal communication skills • Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments • Ability to manage multiple priorities while maintaining exceptional attention to detail and data quality • Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes

🏖️ Benefits

• Medical Aid Contribution • Gap Cover • Life Assurance • Provident Fund (8%) • 13th Cheque • Permanent, full-time employment • Home-based work • Opportunities for continued professional growth and leadership within clinical data management