Project Manager-eClinical Solutions

Octalsoft LLC; Ahmedabad District; On-site; INR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

Collaborative work environment

Job summary

Octalsoft LLC in Ahmedabad is seeking a Project Manager to lead end-to-end implementations of eClinical Solutions for clinical research organizations. You will drive planning, execution, monitoring, and delivery while managing timelines, budgets, and quality in collaboration with Clinical Operations, IT, and QA teams.

The role emphasizes change management, requirements gathering, risk assessment, and alignment with regulatory guidelines (ICH-GCP) to ensure successful adoption of EDC/CTMS systems

Qualifications

• Experience leading eClinical solution implementations (EDC, CTMS) is required.
• Strong understanding of clinical research processes and regulatory guidelines (ICH-GCP).
• Proven ability to manage technology implementations and cross-functional teams.
• PM experience in pharma/biotech/clinical research preferred.

Responsibilities

• Lead end-to-end implementation projects of eClinical Solutions for research organizations.
• Collaborate with Clinical Operations, IT, and QA to define scopes and requirements.
• Develop comprehensive project plans with resource allocation and risk mitigation.
• Coordinate with stakeholders to ensure smooth implementation and adoption.
• Identify opportunities for process optimization and reengineering.
• Champion change management, including training and user support.
• Maintain clear communication with team and senior management on progress.
• Monitor progress, address deviations, and keep projects on track.
• Ensure compliance with regulatory guidelines and industry standards.

Skills

eClinical platforms

Leadership

Communication

Analytical thinking

Change management

SDLC/Agile

Regulatory awareness

PM knowledge

Education

Bachelor's degree in science/engineering

3+ years PM experience

PMP certification (nice-to-have)

ICH-GCP knowledge

Job description

Position: Project Manager - eClinical Solutions

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:

1. 1. 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.
2. 2. 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.
3. 3. Develop comprehensive project plans, including resource allocation, risk assessment, and mitigation strategies, to drive successful execution.
4. 4. Coordinate with internal stakeholders and partners to facilitate the implementation of eClinical Solutions and ensure a smooth implementation process.
5. 5. Identify opportunities for process optimization and reengineering to enhance clinical operations, data collection, and analysis efficiency.
6. 6. Champion change management efforts, including communication, training, and support, to drive user adoption and maximize the benefits of implemented solutions.
7. 7. Establish and maintain effective communication channels with project team members, stakeholders, and senior management to provide regular updates and manage expectations.
8. 8. Monitor project progress, identify deviations from the plan, and proactively resolve issues to keep projects on track.
9. 9. Ensure compliance with regulatory requirements, industry standards, and best practices in all project activities, with a strong focus on Good Clinical Practice (GCP) guidelines.
10. 10. Continuously evaluate the performance and impact of implemented eClinical Solutions, seeking feedback from end-users, and implementing iterative improvements as needed.

Qualifications and Skills:

1. 1. Bachelor's degree or higher in a relevant scientific or technical field.
2. 2. Proven experience (3+ years) as a Project Manager in the pharmaceutical, biotechnology, or clinical research industry, with a strong background in Clinical Operations.
3. 3. 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.
4. 4. Comprehensive understanding of clinical research processes and regulatory guidelines (e.g., ICH-GCP) governing clinical trials.
5. 5. Strong leadership, communication, and interpersonal skills, with the ability to build and lead cross-functional teams effectively.
6. 6. Excellent analytical and problem-solving abilities, with a keen eye for identifying opportunities for process optimization and reengineering.
7. 7. Project Management Professional (PMP) certification is a plus.
8. 8. Familiarity with software development life cycle (SDLC) and Agile methodologies is an advantage.

• we offer a collaborative and dynamic work environment that fosters innovation and professional growth. If you are passionate about transforming clinical research through eClinical Solutions and process reengineering, we encourage you to apply for this exciting opportunity.