Senior Clinical Project Manager

Job Title: Senior Clinical Project Manager

Location: Indianapolis, IN/hybrid

Expected Duration: Long Term

Position Overview:

The Senior Clinical Project Manager for Immunology External Research serves as a critical operational and project management role within the Global External Research and Collaboration (GERC) Immunology team. This position is responsible for driving end-to-end project management across external research studies, maintaining data integrity across external research systems, developing process documentation and training materials, and ensuring seamless execution of governance operations. The ideal candidate will bring strong project management skills, proficiency in tools such as Smartsheet and AI-enabled platforms, exceptional attention to detail, and a passion for building operational infrastructure that enables team excellence.

Key Responsibilities:

Governance Meeting Operations This role serves as the operational backbone for governance review meetings across three therapeutic areas—Gastroenterology, Rheumatology, and Dermatology—each following a three-phase review process conducted on a global platform. The Consultant must develop a strong working knowledge of the GERC Immunology governance framework, including the ability to determine appropriate committee reviewers (10–20 members per therapeutic area) based on research type: pre-clinical, translational, development, HEOR, and Incretins.

Key responsibilities include:

• Reviewer identification, assignment, and phase-by-phase completion tracking

• Pre-read preparation and timely distribution ahead of each governance meeting

• Real-time facilitation and navigation of materials during governance sessions

• Meeting minutes generation, accuracy review, and distribution within 24 hours

• Action item capture, communication, and tracking through to resolution

Communications

• Demonstrate above-standard written and verbal communication skills; this role regularly interfaces with senior scientific, medical, and operational leaders across a global platform and must consistently represent the GERC Immunology team with professionalism and precision

• Communicate reviewer assignments, action items, and governance outcomes clearly and in a timely manner to all relevant internal stakeholders

• Distribute governance meeting pre-reads, agendas, minutes, and follow-up summaries to committee members across therapeutic areas

• Communicate with external investigators and their staff in a professional and responsive manner regarding portal navigation, troubleshooting, and guidance through the governance submission and review process

• Draft and send professional correspondence related to study updates, governance decisions, and process guidance as directed by the GERC Immunology leadership team

• Serve as a reliable communication link between the governance team and cross-functional partners, ensuring information flows accurately and efficiently

Administrative & Stakeholder Support

• Manage complex scheduling for recurring governance meetings and ad hoc sessions required to address key external research topics, resolve issues, and support decision-making across therapeutic areas

• Coordinate and maintain governance meeting calendars proactively, anticipating conflicts and ensuring appropriate participants are engaged

• Serve as a primary point of contact for external investigators and their staff regarding portal navigation, troubleshooting, and guidance on the governance submission and review process

Portal & System Management

• Maintain and update study status in the external research portal following governance review meetings

• Enter study information, submit requests for governance reviews, and record milestone dates for all studies globally

• Ensure portal data accuracy and completeness through regular quality checks and cross-functional collaboration

• Monitor governance activities to ensure timely completion and documentation

Documentation & Knowledge Management

• Clean up and reconcile the SharePoint library connected to the external research portal

• Establish and implement proper folder organization structure aligned with governance workflows

• Identify, organize, and file associated documentation for each study appropriately (protocols, amendments, contracts, correspondence, etc.)

• Reconcile and reorganize previous IIR coordinator team sites to improve information accessibility

• Create and maintain organized folder structures on the current team site that support efficient collaboration

Process Documentation & Training Development

• Develop Standard Operating Procedures (SOPs), work instructions, and process maps for:

• Immunology governance review processes
• Contracting processes
• Supply planning processes
• Other relevant operational workflows
• Create tools and templates that enhance team efficiency and execution excellence
• Partner with IIR coordinators to design comprehensive onboarding and training plans for all GERC team roles
• Build training materials that enable new team members to quickly become proficient in their responsibilities

Cross-Functional Collaboration

• Work closely with IIR coordinators, governance team members, and cross-functional partners to ensure seamless operations

• Collaborate with team members to identify process improvement opportunities

• Contribute to team initiatives that strengthen One MA Immunology culture

Qualifications:

Required:

• Bachelor’s degree in life sciences, business administration, project management, or related field

• 2–4 years of experience in project management, operations, or administrative roles (pharmaceutical/clinical research experience preferred)

• Demonstrated project management skills with ability to independently drive workstreams, manage timelines, and track deliverables across multiple concurrent studies • Strong proficiency in Smartsheet for project tracking, workflow automation, and cross-functional reporting

• Proficiency in Microsoft Office Suite (SharePoint, Teams, Excel, PowerPoint, Word)

• Experience with or demonstrated ability to adopt AI tools (e.g., Microsoft Copilot, generative AI platforms) to enhance productivity and process efficiency

• Exceptional organizational skills with proven ability to manage multiple priorities

• Excellent attention to detail and commitment to data accuracy

• Strong written and verbal communication skills

• Ability to learn complex processes quickly and translate them into clear documentation

Preferred:

• Experience with clinical research operations, investigator-initiated research, or medical affairs

• Familiarity with governance processes, contracting, or supply chain operations in a pharmaceutical setting

• Formal project management training or certification (PMP, CAPM, or equivalent)

• Advanced Smartsheet skills including dashboards, automations, and intake forms

• Experience using AI tools in a professional setting to streamline workflows, summarize information, or generate documentation

• Experience creating SOPs, training materials, or process documentation

• Experience working in global, cross-functional teams