Quanticate
Website:
quanticate.com
Job details:
Description
Join a dynamic and growing clinical research organisation at the forefront of data-driven innovation in clinical trials. We are committed to delivering high-quality, reliable data solutions that accelerate drug development and improve patient outcomes worldwide. Our collaborative, fast-paced environment empowers talented professionals to make a meaningful impact while continuously developing their skills.
This is an exciting opportunity for a detail-oriented and technically strong CDM professional to expand their expertise, contribute to process improvements, and work with industry-leading tools in a highly collaborative environment.
What You’ll Do
Technical Programming & Study Delivery
- Lead and support technical and programming activities for allocated Clinical Data Management projects.
- Review programming requirements and timelines in collaboration with the Manager - CDM Programming and the Lead CDM.
- Ensure programming deliverables are completed to agreed timelines and quality standards.
- Support programming activities required for study reporting and data deliverables.
- Be aware of and work to the standards appropriate to the study.
Quality, Compliance & Governance
- Perform code reviews to ensure programming quality, consistency, and compliance with company standards.
- Conduct internal audits and reviews of study documentation, programming outputs, and processes to ensure compliance with Quanticate standards.
- Perform quality control checks on programming outputs and maintain quality tracking documentation.
- Ensure work is conducted in accordance with study-specific requirements, applicable SOPs, GCP, and regulatory expectations.
- Support system upgrades, implementation activities, and change control processes.
- Assist with programming tasks for reporting of allocated projects, as required.
- Perform quality control checks on programming outputs.
Leadership, Process Improvement & Operational Support
- Lead and mentor junior programmers, providing guidance, training, and issue resolution support.
- Drive continuous improvement activities in collaboration with the Manager - CDM Programming.
- Initiate and implement process improvement ideas and provide recommendations for enhancements to procedures and standards.
- Manage user administration activities, including user access management, user access reviews, and e-learning assignments.
- Work with the Manager - CDM Programming on process improvement tasks.
- Initiate and implement process improvement ideas.
- Provide opinions and recommendations on possible improvements to procedures and standards.
Clinical Database Development & Configuration
- Annotate the master CRF.
- Assist with the definition of clinical databases and the setup and testing of data entry screens.
- Set up electronic consistency checks where required.
- Assist with the writing and testing of edit checks.
Data Integration & Processing
- Set up imports of electronic data as required.
- Assist with the setup of systems used for study processing.
- Prepare electronic data exports and associated documentation for study completion and data transfer activities.
- Perform User Management activities, including user access management, user access reviews, and e-learning assignments.
Project Coordination & Communication
- Report progress against project schedules to the Project Data Manager or Lead Clinical Data Manager.
- Communicate effectively with internal and external customers regarding project activities and deliverables.
- Perform other reasonable tasks as requested by management.
What You’ll Gain
- Hands-on experience with leading EDC platforms and advanced clinical programming tools.
- Exposure to global clinical trials and collaboration with sponsors and cross-functional teams.
- Opportunities to contribute to process improvements and innovation initiatives.
- Continuous learning through training, literature, and professional development programs.
- Experience in a dynamic, matrix-structured work environment.
Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Requirements
Knowledge
- Knowledge of industry-standard systems such as SDTM, CDISC, and CDASH.
- Knowledge of EDC systems and clinical database technologies, including Medidata Rave and Medrio.
- Understanding of Clinical Data Management processes.
- Thorough knowledge of ICH Guidelines, Good Clinical Practice (GCP), and applicable regulatory requirements.
Work Experience
- 4+ years of experience in the pharmaceutical industry.
- Strong experience in a technical/programming role within the pharmaceutical industry, preferably within Clinical Data Management.
Skills
- Proficiency in EDC platforms such as Medidata Rave, Veeva, Medrio, Viedoc, etc.
- Strong knowledge of SAS and clinical programming concepts.
- Experience with programming languages such as PL/SQL, SAS, C#, or VB (preferred).
- Familiarity with edit checks, derivations, database setup, and data validation processes.
- Experience with application programming and system integrations.
- Strong understanding of quality standards and SOP-driven environments.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Ability to collaborate with internal teams and external stakeholders effectively.
- Experience in a matrix organisational structure is an advantage.
Quanticate will
never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we
do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.
Benefits
- Competitive salary
- Flexible working hours
- Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
- Medical Insurance for self and immediate family
- Gratuity
- Accidental Coverage
- Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)
Click on Apply to know more.
