Cliantha is currently seeking a Clinical Systems Specialist who can fulfill its business needs and is looking for better learning and growth opportunities.
Cliantha Research is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA, Canada & Europe.
- Creating, implementation and management of Clinical Systems Project Plan which includes but is not limited to:
- Identification of Clinical Systems (CS) equipment, systems, services, resources, and anticipated date of first use.
- Setup and training for any validated electronic data capture or ePDAT/EPRO systems being managed by the CS department.
- Preparation and oversight of any administrative systems managed by the CS department used to facilitate the management of study participants.
- Identification of, source and qualify/validate any novel equipment or systems required for the project conduct.
- Identify, implement, monitor, and assess impact of process/efficiency improvements.
- Development of SOPs, Equipment Binders, templates.
- Assist with the calibration, training and project implementation for all CS equipment and systems.
- Write or contribute to instructions or manuals to guide end users.
- Manage training of staff as experience and qualifications permit.
- Prepare and execute Environmental Exposure Chamber (EEC) validations.
- Assist in preparations, logistics and Re-Qualification of any mobile EEC (mEEC).
- Develop and execute test scripts as well as assist with all aspects of any CS validation.
- Perform scheduled documentation review on all systems.
- Ensure compliance with Cliantha Research SOPs, GLP, GDP and ICH guidelines.
- Represent Cliantha Research in a respectful and business-like manner at all times.
- Other duties as may be required.
Positions Directly Supervised:
- Sc., post-secondary diploma in scientific, healthcare, or pharmaceutical field, or equivalent
- Minimum2 years of experience in clinical research environment.
- Very strong analytical and problem solving skills, capable of assessing situation and providing recommendation on problem remediation.
- Excellent organizational skills, detail oriented, efficient and able to multi-task competing projects and prioritize appropriately.
- Excellent interpersonal communication and writing skills.
- Solid understanding of applying abductive and deductive reasoning to logic-based systems.
Why Cliantha Research?
- Competitive Salary.
- Medical, Dental, Vision, and Life Insurance.
- An exciting opportunity for learning and development!
Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought in by all our employees and clients. If you require accommodation before, during, or after the interview/recruitment process do not hesitate to let us know when we contact you and we will work with you and do our level best to meet your needs.
Job Types: Full-time, Permanent
Ability to commute/relocate:
- Mississauga, ON L4W 1A4: reliably commute or plan to relocate before starting work (preferred)
Work Location: In person