Project Lead Developer (Rave/Python/SAS Project Management)

Project Role: Lead Developer

Work Experience: 8 + Years

Work location: Any IQVIA Office Location in India

Work Mode: Hybrid

Job Overview:

Oversee the design, development, and implementation of data management systems in support of clinical trials. This role involves managing Electronic Data Capture (EDC) systems, ensuring quality data review processes, and integrating platforms. Will act as a client liaison representing clinical database programming and associated lead activities. Collaborate with Cross-functional teams including clinical operations, biostatistics, and IT as needed to ensure the accuracy, integrity, and security of clinical data.

Essential Functions:

• Lead Developer participates in activities related to specification development, programming, validation and quality assurance of study data deliverables and applies expert experience and knowledge.
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  This role has responsibilities, which include planning, assigning, and guiding the Team in study start up, maintenance and close out activities. Also, responsible for managing multiple projects in accordance with established timelines and quality standards.
• Work closely with clinical teams, data managers, and other stakeholders to ensure data needs are met.
• Support on project financials check & review.
• Create and manage reports, graphs, and summaries to support clinical trial activities.
• Participate in the development and implementation of new processes and technology.
• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff.
• Oversee timely delivery of multiple study deliverables with quality.
• Provide reporting and status information for all build activities for active studies.
• Anticipate and communicate any project risks to respective stakeholders, including the risk for missing any timelines in the Data Management Project Plan.
• Facilitate audit trail reports in accordance with data management guidelines.
• Handle quality issue escalations and facilitate on CAPA closures.

Required Knowledge, and Skills:

• Strong understanding of the purpose and content of study documents.
• Excellent technical knowledge of technical tools and processes (e.g. Medidata Rave, ALS etc) and protocol interpretation skills.

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• Complete understanding of the database and capable of handling questions from the sponsor and internal team and provide solutions. End to end knowledge of data management processes will help to understand the impact of database set-up on the conduct phase.
• Ability to work meticulously to ensure data accuracy and compliance with protocols.
• Ability to independently identify and resolve programming issues.
• Effective communication with clinical teams and stakeholders to understand and translate data requirements.
• Ability to manage multiple projects and meet deadlines.

Qualifications:

• Bachelors or Masters degree in Computer Science, Data Management, Life Sciences, or a related field.
• 8+ years of experience in clinical data management with a focus on EDC, data review, and analytics.
• Proven experience managing teams and leading clinical data system development.
• Proficiency in EDC systems such as Medidata Rave
• Experience with data analytics platforms such as SAS, Spotfire, or Power BI is an add-on advantage.
• Strong knowledge of clinical trial processes, regulatory requirements, and GCP guidelines.
• Excellent communication and problem-solving skills.