Project Manager-eClinical Solutions

Octalsoft; Ahmedabad District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Octalsoft is seeking an experienced Project Manager to lead the implementation of eClinical Solutions for clinical research organizations. You will coordinate with Clinical Operations, IT, and QA to drive process reengineering and optimize data management workflows.

The role requires 3+ years in pharma/clinical project management, with hands-on experience in EDC and CTMS, and strong leadership abilities to drive adoption and ensure GCP compliance.

Qualifications

• Bachelor's degree or higher in a relevant field.
• 3+ years as a Project Manager in pharma/biotech/clinical research.
• Experience with eClinical solutions (EDC, CTMS) and related tools.
• Strong knowledge of ICH-GCP and clinical trial processes.
• Proven leadership, communication, and cross-functional collaboration.
• Analytical and problem-solving abilities with process optimization focus.
• PMP certification is a plus.
• Familiarity with SDLC and Agile methodologies is an advantage.

Responsibilities

• Lead end-to-end implementation projects of eClinical Solutions for research orgs.
• Collaborate with Clinical Ops, IT, and QA to define scopes and requirements.
• Develop project plans with resource allocation and risk measures.
• Coordinate with stakeholders to ensure smooth implementation.
• Identify opportunities for process reengineering to improve workflows.
• Drive change management including training and user adoption.
• Maintain communication with team and senior management on progress.
• Monitor progress and resolve deviations to keep on schedule.
• Ensure adherence to regulatory standards (GCP) in all activities.

Skills

Leadership

Communication

Interpersonal skills

Analytical thinking

Problem-solving

Change management

SDLC awareness

Agile familiarity

Education

Bachelor's degree or higher in a scientific/technical field

PMP certification

Tools

EDC systems

CTMS

Regulatory compliance tools

Job description

Job Summary

As a Project Manager, you will play a pivotal role in spearheading the successful implementation of eClinical Solutions for clinical research organizations. Working closely with cross-functional teams, including Clinical Operations, IT, and Quality Assurance, you will drive process reengineering initiatives to optimize clinical operations workflows and enhance data management efficiency. The ideal candidate will be instrumental in managing changes related to technology implementation, ensuring seamless adoption and alignment with organizational objectives.

Key Responsibilities

• Lead and manage end-to-end implementation projects of eClinical Solutions for research organizations, from planning and execution to monitoring and delivery, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with external stakeholders, including Clinical Operations and/or Clinical Data Management, to gather requirements and define project scopes for technology implementation and business process reengineering initiatives.
• Develop comprehensive project plans, including resource allocation, risk assessment, and mitigation strategies, to drive successful execution.
• Coordinate with internal stakeholders and partners to facilitate the implementation of eClinical Solutions and ensure a smooth implementation process.
• Identify opportunities for process optimization and reengineering to enhance clinical operations, data collection, and analysis efficiency.
• Champion change management efforts, including communication, training, and support, to drive user adoption and maximize the benefits of implemented solutions.
• Establish and maintain effective communication channels with project team members, stakeholders, and senior management to provide regular updates and manage expectations.
• Monitor project progress, identify deviations from the plan, and proactively resolve issues to keep projects on track.
• Ensure compliance with regulatory requirements, industry standards, and best practices in all project activities, with a strong focus on Good Clinical Practice (GCP) guidelines.
• Continuously evaluate the performance and impact of implemented eClinical Solutions, seeking feedback from end-users, and implementing iterative improvements as needed.

Qualifications and Skills

• Bachelor's degree or higher in a relevant scientific or technical field.
• Proven experience (3+ years) as a Project Manager in the pharmaceutical, biotechnology, or clinical research industry, with a strong background in Clinical Operations.
• Demonstrated expertise in managing technology implementation projects, particularly eClinical Solutions such as Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and related tools.
• Comprehensive understanding of clinical research processes and regulatory guidelines (e.g., ICH-GCP) governing clinical trials.
• Strong leadership, communication, and interpersonal skills, with the ability to build and lead cross-functional teams effectively.
• Excellent analytical and problem-solving abilities, with a keen eye for identifying opportunities for process optimization and reengineering.
• Project Management Professional (PMP) certification is a plus.
• Familiarity with software development life cycle (SDLC) and Agile methodologies is an advantage.