Clinical Developer

This is a fully remote position, open to applicants in India.

📋 Description

• Develop and sustain clinical trials for clients.

• Work in collaboration with clients and internal teams to ensure clinical trials are accurate, comprehensive, and fully operational.

• Record requirements for study builds, modifications, and overall project tasks and timelines.

• Validate clinical trials created to confirm accuracy before progressing to Quality Assurance.

• Implement mid-study change requests to maintain timely and accurate project workflows.

• Manage study fixes for all clinical trials according to Technical Support Services escalation procedures.

• Attend Customer and Management meetings as necessary.

• Supervise Clinical Development as required to address technical challenges.

• Resolve issues escalated to Clinical Development in line with Customer Care escalation protocols.

• Estimate and allocate project tasks to ensure effective workload management across the team.

• Collaborate with stakeholders and clients to define and map requirements, converting them into reports.

• Identify and map data, creating new reports utilizing SQL queries.

• Develop software in alignment with industry regulations, such as 21 CFR Part 11.

⛳️ Requirements

• Capacity to thrive in a highly collaborative, fast-paced team setting.

• Exceptional analytical abilities with the capability to juggle multiple priorities and requests.

• Outstanding communication and interpersonal skills.

• Demonstrated leadership experience to provide appropriate direction to Clinical Developers.

• Proficient problem solver with a keen attention to detail.

• Expertise in Anju Software's clinical products, or the ability to quickly gain proficiency.

• Ability to work autonomously in a dynamic environment.

• Strong communication and documentation abilities.

• Robust work ethic and eagerness to learn.

• Excellent follow-up skills for problem resolution to ensure timely handling of all projects.

• Proven technical leadership in a team context.

• Bachelor's degree in a related field or relevant work experience.

• At least 4+ years of experience with DHTML (HTML + JavaScript).

• Comprehensive understanding of SQL and IIS.

• Strong project management capabilities.

• Established leadership skills.

• Knowledge of clinical trial design and setup.

• Familiarity with GCP/ICH guidelines for conducting clinical trials.

• Understanding of FDA regulations and/or experience in the life sciences sector is preferred.

🏝️ Benefits

• Provident Fund (PF) contributions.

• Medical and term insurance coverage, as per company policy.

• Paid time off including vacation, personal and sick leave, floating holidays, and public holidays.

• Reimbursement for approved work-related travel expenses.