Clinical Data Manager Home-based - FSP Job Bloemfontein South Africa,IT/Tech

Position: Clinical Data Manager Home-based) - FSP

When our values align, there's no limit to what we can achieve.

Parexel is currently seeking a Clinical Data Manager to join us in South Africa, dedicated to a single sponsor.

This role will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. The successful candidate will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I – IV studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance.

Working as a Clinical Data Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

This will be a fully remote home-based position. RAVE experience is strongly preferred.

Responsibilities

Lead a small clinical study or a co-lead a larger study or studies with moderate guidance.

Be able to support several clinical studies with minimal guidance.

Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.

Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.

Be able to perform a thoroughly detailed review of eCRF data requirements.

Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.

Develop data edit check specifications and run data listings as required.

Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.

Develop the Data Management Plan for a clinical study.

Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.

Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.

Perform reconciliation of header data from external data sources against the clinical database.

Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.

Assist in database upgrades/migrations including performing User Acceptance Testing.

Able to maintain study workbooks and data management files.

Perform database lock and freeze activities per company SOPs.

Participate in regular team meetings and provide input when appropriate.

Provide input into the development of data management SOPs, Work Instructions, and process documents.

Assist with the training of new employees and/or contractors.

Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.

Here are a few requirements specific to this advertised role.

Bachelor’s Degree required (master’s preferred), preferably in the scientific/healthcare field.

At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry.

Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors.

An understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.

Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

Detail-oriented with a proven ability to multitask and work independently. Excellent time management and organizational skills, with highly developed problem-solving and analytical abilities.

Strong English language written and verbal communication skills.

Able to travel to meetings or training…