Project Manager background; CTMS & eTMF at Foster , CA; Onsite

Project Manager with BA Background (CTMS & eTMF)

Location:

Foster City, CA (Onsite)

Duration: FTE

We are seeking a Project Manager and Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery. Hands-on experience with clinical systems such as CTMS, eTMF, RBQM, and EDC is highly preferred.

The role requires excellent communication and problem-solving skills, along with proven ability to work with business teams to refine requirements and ensure alignment with project goals and deliverables.

• Experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders.

• Clinical domain and operations, including hands-on experience with systems like CTMS, eTMF, RBQM, and EDC.

• Experience in creating detailed BRDs, user stories, and acceptance criteria, and collaborating with technical teams to define specifications and designs.

• Experience coordinating with development and QA/UAT teams, supporting test planning, reviews, and ensuring deliverables meet business requirements.

• Experience working with project managers and business teams to align scope, refine requirements, and support successful project delivery.

This position is critical for customer who can independently handle all PM and customer coordination with BA experience at Onshore.

Communication

Skills:

Communicate effectively with internal and customer stakeholders

Communication approach: verbal, emails and instant messages

Interpersonal

Skills:

Strong interpersonal skills to build and maintain productive relationships with team members

Provide constructive feedback during code reviews and be open to receiving feedback on your own code.

Problem-Solving and Analytical Thinking:

Capability to troubleshoot and resolve issues efficiently.

Analytical mindset

Task/ Work Updates

Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure Dev Ops

Provides regular updates, proactive and due diligent to carry out responsibilities

The Business Analyst will ensure that business requirements are clearly understood, documented, and translated into actionable deliverables, leading to the successful implementation of clinical systems and processes. The role is expected to drive alignment between stakeholders, technical teams, and project managers, ensuring that all solutions meet business objectives, comply with industry standards, and are delivered on time with high quality.

In addition to core business analysis expertise, the candidate should bring secondary skills such as knowledge of regulatory guidelines (e.g., 21 CFR Part 11 and GxP compliance), familiarity with Agile/Scrum methodologies and tools like Jira, Azure Dev Ops, or HP ALM, and strong SQL and data analysis capabilities to support requirement validation and testing. Proficiency in MS Office tools (Excel, PowerPoint, Visio, Project) for documentation and presentations, along with experience in preparing training materials, user guides, and process documentation, will be valuable.

The ability to facilitate workshops, requirement sessions, and stakeholder discussions is also expected.

To be part of one of the most important engagements for our customer, supporting PM for risk based monitoring system

Gain hands-on experience across Veeva applications while building expertise in incident management, access provisioning, and workflow troubleshooting.

Benefit from a strong learning curve with exposure to integrations and clear growth opportunities