Senior Bridge Engineer - Remote Leadership On Projects

Placements24; Klerksdorp; Remote; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Medical Aid Contribution

Gap Cover

Life Assurance

Provident Fund (8%)

13th Cheque

Zusammenfassung

Parexel is seeking a Senior Clinical Data Associate to join our team in South Africa on a remote basis. You will support global clinical studies from Phase I–IV, driving data quality, regulatory compliance, and study deliverables across CROs and vendors.

You will lead data management activities, coordinate EDC systems, develop study documentation, and contribute to database locks, listings, and inspection readiness in a fast-paced sponsor environment.

Qualifikationen

• Bachelor's Degree in a scientific or healthcare-related field.
• At least five years' experience in Data Management within the pharmaceutical/biotech industry.
• Understanding of Phase I–IV studies and data management activities with vendors.
• Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries.
• Experience with EDC systems; RAVE experience strongly preferred.
• Strong communication, organization, technical, and problem-solving skills.

Aufgaben

• Lead a clinical study or co-lead larger studies with moderate guidance.
• Support multiple studies ensuring high data quality and timely delivery.
• Manage data management activities performed by CROs and vendors.
• Review protocols and data capture requirements, including eCRF design.
• Collaborate with CRAs, programmers, statisticians to develop annotated eCRFs.
• Develop data edit check specifications and study data listings.
• Coordinate EDC system design, testing and issue resolution.
• Maintain Data Management Plans and supporting documentation.
• Perform query management, data reconciliations, and SAE reconciliation.
• Support database upgrades, migrations, testing, and database lock activities.
• Maintain study workbooks and ensure inspection readiness.
• Contribute to SOPs and process documentation improvements.

Kenntnisse

Attention to detail

Analytical thinking

Organizational skills

Communication skills

Team collaboration

Ausbildung

Bachelor's Degree in a scientific or healthcare-related field

Tools

Electronic Data Capture (EDC) systems

RAVE

Jobbeschreibung

Senior Clinical Data Associate – Parexel

Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient‑focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry‑leading innovation, With Heart®.

We are seeking a Senior Clinical Data Associate to join our team in South Africa in a remote capacity.

As a Senior Clinical Data Associate, you will support global clinical research programs by delivering high‑quality data management activities across Phase I‑IV clinical studies. This position plays a key role in clinical data quality, regulatory compliance, study execution, and cross‑functional collaboration. You will partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management activities. Responsibilities include supporting and leading data management activities, coordinating Electronic Data Capture (EDC) systems, developing study documentation, and contributing to database lock and study deliverables. You will join a fast‑paced, growth‑oriented environment dedicated to a single sponsor and supporting important commercial and development programs worldwide. This role offers the opportunity to contribute directly to clinical research that advances new therapies while expanding your expertise across data management processes, clinical technologies, and cross‑functional study operations.

• Lead a small clinical study or co‑lead larger studies with moderate guidance.
• Support multiple clinical studies while ensuring high standards of data quality and delivery.
• Manage and monitor data management activities performed by CROs and external vendors.
• Review study protocols and evaluate data capture requirements, including electronic Case Report Form (eCRF) design.
• Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines.
• Develop data edit check specifications and generate study data listings as required.
• Coordinate the design, testing, and issue resolution of Electronic Data Capture systems in accordance with company standards.
• Develop and maintain study Data Management Plans and supporting documentation
• Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities.
• Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities.
• Maintain study workbooks and data management files while ensuring inspection readiness.
• Contribute to the development and improvement of data management SOPs, work instructions, and process documentation.

• Strong attention to detail, analytical thinking, and organizational skills.
• Experience working within clinical research and regulated pharmaceutical or biotechnology environments.
• The ability to collaborate effectively across multidisciplinary teams as well as with external partners and vendors.
• A patient‑focused mindset with a commitment to data quality and regulatory compliance.
• Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms.

• Bachelor's Degree in a scientific or healthcare‑related field.
• At least five years' experience in Data Management within the pharmaceutical or biotechnology industry.
• Understanding of Phase I‑IV clinical studies and demonstrated ability to perform core Data Management activities and work with vendors.
• Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards.
• Experience with Electronic Data Capture systems and clinical data management technologies. RAVE experience is strongly preferred.
• Strong communication, organization, technical, and problem‑solving skills.

• Experience in Oncology or CNS therapeutic areas.
• Experience supporting Phase III pivotal studies.

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

Onsite

Remote South Africa

Full time

JR

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.