Clinical Operations Systems SME

4 weeks ago

Hubli, Karnataka, India Oxford Global Resources Full time
Job Description
We are seeking a highly skilled and experienced Senior Technical Subject Matter Expert (SME) to support our client's Clinical early phase systems and associated study supported tools. The ideal candidate will possess deep technical knowledge and hands-on experience with these systems, along with a strong understanding of Clinical Operations. This role will involve providing technical leadership, system optimization, and ensuring seamless integration and functionality of our clinical systems.

6-months contract.

Responsibilities

- Serve as the primary technical expert for systems.
- Lead the implementation, configuration, and maintenance of Veeva systems to support clinical trials and operations.
- Collaborate with cross-functional teams including Clinical Operations, IT, and external vendors to ensure system alignment with business needs.
- Provide technical guidance and support for system integrations, data migrations, and upgrades.
- Develop and maintain system documentation, including technical specifications, user guides, and SOPs.
- Troubleshoot and resolve technical issues related to Veeva systems, ensuring minimal disruption to clinical operations.
- Conduct training sessions and workshops for end-users to enhance system utilization and efficiency.
- Stay current with industry trends and advancements in clinical systems and technology to recommend improvements and innovations.
- Ensure compliance with regulatory requirements and company policies in all system-related activities.

Requirements

- Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 7-10 years of experience in a technical role supporting clinical systems, with at least 5 years specifically working with Veeva Clinical CTMS, eTMF, and CDMS.
- Strong understanding of clinical trial processes and regulatory requirements.
- Proven experience in system implementation, configuration, and maintenance.
- Excellent problem-solving skills and the ability to troubleshoot complex technical issues.
- Strong communication and interpersonal skills, with the ability to work effectively with diverse teams.
- Experience with system integrations, data migrations, and upgrades.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Certification in Veeva systems is a plus.
- Technical Skills:
- Knowledge with participant enrolment, randomization, investigational product dispensing, trial supply inventory management and participant visit tracking.
- Hands on experience with Evident IQ Marvin, Planisware, Almac IRT, SOCAR eSOCDAT, Clinical ink eLAS
- Experience with Veeva Clinical CTMS, eTMF, and CDMS systems.
- Knowledge of SQL, database management, and data analysis.
- Familiarity with clinical data standards (e.g., CDISC, SDTM).Experience with cloud-based solutions and SaaS platforms.
- Understanding of GxP, 21 CFR Part 11, and other regulatory requirements.
- Statistical analysis tools SAS server, PC SAS, R studio, Qlik, CDISC tools Pinnacle 21, RYZE experience is a plus.

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