Advarra

• Support IRB meeting preparation and coordination: Review submissions for full board assignment to ensure readiness for review • Assign submissions to upcoming IRB meetings, as directed • Send assignments and assignment updates to reviewers in CIRBI • Send clarifications between Client Services and Board reviewers in collaboration with Senior Meeting Coordinator • Assist with preparation of Meeting and Postmeeting ICFs, as directed • Assist with preparing meeting determinations in collaboration with Senior Meeting Coordinator • Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada,TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions • Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards • Apply negotiated language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s. • Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders • Complete informed consent quality control check for self and others • Maintain and increase individual regulatory knowledge to assist with organizational compliance • Maintain and increase knowledge of U.S. and/or Canadian Federal Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research • Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management • Complete organizational training as required by management • Attend a minimum of four IRB meetings per month to enhance knowledge and understanding of IRB processes • Offers process improvement suggestions to management • Other duties as assigned

• Collaborates with management and Team Lead to drive process enhancements and contributes to the execution of departmental and company strategies • Acts as a point of contact for IRB customers and provide exceptional customer service to enhance the client experience • Demonstrates comprehensive understanding across various IRB processes and submission requirements • Proactively supports the clients, both internal and external, by assisting in a variety of tasks • Ensures timely responses to customer inquiries

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing) • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Provide written audit reports in English. • If required will provide corrective actions support and present findings to QA leadership and stakeholders • Work collaboratively with clients to ensure quality standards.

• Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing) • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Provide written audit reports in English. • If required will provide corrective actions support and present findings to QA leadership and stakeholders • Work collaboratively with clients to ensure quality standards.

• Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing) • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Provide written audit reports in English. • If required will provide corrective actions support and present findings to QA leadership and stakeholders • Work collaboratively with clients to ensure quality standards.

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing). • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Provide written audit reports in English. • If required will provide corrective actions support and present findings to QA leadership and stakeholders. • Work collaboratively with clients to ensure quality standards.

Role Description The purpose of this role is to lead the company’s customer-facing product implementations as well as support internal organizational initiatives. The Senior Project Manager is responsible for the direction, coordination, and completion of all projects/implementations while remaining aligned with overarching goals and priorities. This role is also responsible for supporting the people management of the Project Management team and should be able to mentor and develop more junior members of the team. Job Duties & Responsibilities - Orchestrate and drive the successful and timely completion of tasks to achieve customer organizational goals, including the identification and mitigation of risks and issues which may impact the project. - Work with customers and internal team members to recommend necessary project resources and responsibilities, define project scope, and develop a project schedule. - Communicate effectively and build strong relationships with all project stakeholders, including project sponsors, subject matter experts, and project team members in a timely and consistent manner. - Review and monitor project work to ensure forward progress is made and work is completed on time and within budget. - Identify, monitor, and communicate project-related issues including scope changes that may arise during the implementation. - Facilitate, coordinate, and arbitrate cross-functional discussions and decisions with subject matter experts within key functional areas. - Understand the organization’s strategic priorities and adapt project timelines and tasks accordingly. - Lead onsite and offsite meetings and training events. - Work with customers to review and validate application configuration options. - Drive data migration activities, including data mapping, validation, and issue resolution. - Drive internal projects to completion, ensuring team members stay on track, risks are identified, and issues resolved in a timely manner. - Share and encourage others to share and use the lessons learned from project work in order to identify and implement process improvements. - Contribute to our implementation and software documentation. - Act as expert resource for Product Support Specialists, Business Analysts, and other departments in all functional and content areas associated with a project. - Contribute project experience to the knowledge library. - Effectively serve as an informal manager to the project team, despite lack of direct reporting relationships. - Provide input to project teammates on a regular basis for ongoing performance reviews. - Coach to develop team and individual team members’ skills. - Partner with Director, Project Management on any people related matters. - Perform other job-related duties as assigned. Qualifications - Bachelor’s Degree or relevant experience. - 8-12 years of experience managing medium-to-scale implementation projects using a standard project management methodology. - Experience identifying and implementing process improvements. - Experience presenting and leading customer-facing group discussions with confidence and conciseness. - Experience effectively negotiating and building consensus with various audiences and managing project activities. Preferred Qualifications - Project Management Certification (PMP). - 2+ years of experience in the clinical research industry. - Prior managerial experience. - Demonstrated organizational skills including attention to detail and multi-tasking skills. - Ability to travel up to 25%. - Excellent verbal and written communication skills. - Strong working knowledge of Microsoft Excel, Word, PowerPoint, and Visio. - Experience using MS Project and MS Access. - Business analysis experience in process definition, gap analysis, and workflow design. - Data migration experience including data mapping and validation. Physical and Mental Requirements - Sit or stand for extended periods of time at stationary workstation. - Regularly carry, raise, and lower objects of up to 10 Lbs. - Learn and comprehend basic instructions. - Focus and attention to tasks and responsibilities. - Verbal communication; listening and understanding, responding, and speaking. Benefits - Base salary range for this role is $94,886 - $173,957. - Salary may vary based on location, skills, and experience. - This position may also be eligible for a variable bonus in addition to base salary. - Health coverage, paid holidays, and other benefits.

• Sell Advarra products and services to customers and prospects in assigned segment • Manage a pipeline from initial discovery to contract signature • Achieve booking, revenue, and profit objectives within assigned account territories • Identify sales opportunities through daily prospecting, qualifying opportunities • Leverage Advarra resources to bring opportunities to a successful conclusion • Maintain a pipeline of prospective clients and opportunities in the CRM system • Close sales transactions with clients and prospects • Collaborate with the Contracts & Legal team to organize mutual NDAs, MSAs, etc. • Partner with Advarra’s Service & Solution Sales Teams (SSDs) to support pipeline progression • Collaborate with the marketing and sales teams to follow up on leads generated from campaigns • Deliver presentations and product demonstrations virtually • Maintain and update contact, account and opportunity data within company systems • Provide exceptional customer service and maintain strong client relationships • Prepare and deliver accurate sales reports and forecasts to management

• Master complex software applications, integrations and reports and their use within the clinical research industry • Work with new customers to fully understand their current business processes and workflows while assisting with the implementation of technological solutions • Map current state workflows into new, future state application workflows using process flow charting • Develop and utilize use cases to analyze, define and document business requirements and application scenarios • Provide guidance to internal stakeholders on customer enhancement requests • Coordinate with other internal teams as necessary, to develop Statements of Work (SOWs) required to support new and implementing customers • Assist in the completion of technical RFP questions for prospective customers • Build a strong relationship with the customer project team to help ensure the success of the implementation • Provide guidance to customers on best practices for integrating Advarra technology solutions into their research operations environment • Work closely with the implementation project manager to ensure on-time delivery of all milestones • Perform other job-related duties as assigned.

• Conduct Quality Control (QC) activities on complex IRB and staff documentation to ensure accuracy compared to primary sources • Reviews and critically analyzes documents for accuracy in content for assigned submission types • Provides clear feedback to communicate errors to Research Services staff regarding missing and/or incomplete elements • Accomplishes daily workload priorities with flexibility and adaptability • Executes procedures in compliance with internal quality standards and external regulations • Participate in team and department professional and personal development initiatives