Position Summary
The Clinical Developer designs, develops and maintains clinical trial studies from initial build throughout the entire project lifecycle. This role also provides management oversight and training to Clinical Trial Developers for study build projects.
Responsibilities
- Build and maintain clinical trials for customers.
- Collaborate with customers and internal resources to create accurate, complete and fully functional clinical trials.
- Document study build requirements, changes, and overall project tasks and timelines.
- Test clinical trials developed to ensure accuracy prior to moving into Quality Assurance.
- Execute mid-study change requests to ensure project workflow is timely and accurate.
- Maintain study fixes for all clinical trials based on Technical Support Services escalation processes.
- Participate in Customer and Management meetings as needed.
- Oversee Clinical Development as needed to resolve technical issues.
- Troubleshoot incidents escalated to Clinical Development following Customer Care escalation processes.
- Estimate and assign project tasks to ensure workload is properly managed and distributed across the team.
- Work with stakeholders and customers to create and map requirements and convert them to reports.
- Identify and map data and create new reports using SQL queries.
- Develop software in compliance with industry regulations such as 21 CFR Part 11.
Requirements
Personal Qualities
Ability to function in a highly collaborative, fast-paced team environment. Excellent analytical skills with the ability to manage multiple priorities and requests. Excellent communication and interpersonal skills. Proven leadership experience to ensure proper guidance is provided to the Clinical Developers.
Skills Needed
- Expert problem solver with attention to detail.
- Proficiency in Anju Software's clinical products, or the ability to quickly become proficient.
- Ability to work independently in a fast-paced environment.
- Excellent communication and documentation skills.
- Strong work ethic and willingness to learn.
- Excellent problem resolution follow-up skills to ensure all projects are handled in a timely manner.
- Proven technical leadership in a team environment.
Qualifications Needed
- Bachelor's degree in a related field of study or related work experience.
- Minimum of 4+ years of experience with DHTML (HTML + JavaScript).
- High-level understanding of SQL and IIS.
- Solid project management skills.
- Proven leadership skills.
- Knowledge of clinical trial design and setup.
- Understanding of GCP/ICH guidelines for the conduct of clinical trials.
- Knowledge of FDA regulations and/or experience within the life sciences industry preferred.
Benefits
- Provident Fund (PF) contributions
- Medical and term insurance coverage, per company policy
- Paid time off: vacation, personal and sick leave, floating holidays and public holidays
- Reimbursement of approved work-related travel expenses