Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating drug development and commercialization. The Project Manager role is responsible for the day-to-day oversight and close out of patient concierge projects, coordinating with various teams and ensuring compliance with clinical SOPs and regulatory requirements. This position involves managing project budgets, vendor relationships, and client communications to deliver successful clinical trial support services.
Responsibilities
- Be responsible for the day-to-day oversight and close out of allocated patient concierge projects and to liaise with the PCS Coordination team, Finance, and IT (INFORMATION TECHNOLOGY), delivering the project until completion in accordance with the appropriate clinical SOPs (Standard Operating Procedures), GCP (Good Clinical Practice) and all applicable regulatory requirements
- Provide project specific training to the PCS coordinators assigned to the team and oversee their project work
- Attend project handover meetings from GPSU and kick-off meetings where necessary with clients, gaining an understanding of the study indication, patient demographic, project budget, PCS deliverables and timelines
- Work with the PCS Concierge Coordinators (PCS PCCs) to arrange the set-up of the trial environment within the PatientGO portal
- Lead the process of document creation and translation for site and ethics ready patient facing material, in conjunction with the global start-up team. Give guidance to the client on Travel and Expense Reimbursement Policy set-up and management, with the aim to minimise patient burden and maximise the potential of their retention
- Develop a clear understanding of the study budget and its scope, managing it to the point of completion and reconciliation. Prepare accurate financial and activity forecasts for the lifetime of the project and report actual performance against forecast. Prepare monthly invoices based on project activity. Identify changes in scope and seek client approval for change orders
- Manage external vendors providing services to the project ensuring they meet Service Level Agreements and other contractual agreements
- Conduct monthly project reviews and report progress identifying achievements and issues with overall study progress, finances, client relationships, project risks, resource, and vendors. Attend project review meetings as required and escalate issues to Senior Management
- Work to generate opportunities for collaboration with Illingworth s Research Nursing and Medical Imaging divisions, to help deliver holistic solutions for the benefit of clients and their patients
- Stay informed on the requirements of your role, the industry and challenges faced by patients and clients across the therapeutic areas PCS supports, identifying personal development opportunities and training needs for you and your colleagues. Maintain and share knowledge of all relevant guidance, regulations, and procedures with other PCS team members to ensure best practice
- Work with PCS PCC team to set up and distribute expense reimbursement materials and patient welcome packs and lead the creation of new content where necessary
- Maintain effective project related communications between the other Illingworth business units, clients, clinical trial sites and vendors to ensure excellent relationships continue and all parties are kept up to date with project progress. This includes sending invitations, leading meetings, and taking notes of discussion points and actions to share with attendees post-meeting in a timely manner. In the event that PCS is collaborating on a project with IRG s Research Nursing (RN) division, coordinate with RN Project Leads to ensure a joined-up approach for the client
- Review and approve project timesheets, comparing work completed against visit trackers and budget allowances, requesting team members to correct entries where required
- Participate in possible face-to-face client and vendor related meetings, these will require travel both home and abroad
- Working with the Director of Patient Concierge Services and Business Development to develop and grow the service and team
- Retain the lead whilst working closely with the PCS Commercial Manager to ensure all change orders are executed in a timely and efficient manner
- Ensure that assigned projects centrally stored oversight trackers are complete and up to date always, to ensure appropriate business continuity measures are met
- For allocated projects, upon handover from the Illingworth Global Project Start-Up (GPSU) team be the first point of contact for both CRO (Contract Research Organisation) and sponsor clients, project issues, heads of trial sites, vendors, and Illingworth business units and functions, liaising with the AD PCS and Senior Director of PCS for issue management and resolution
Benefits
- Remote work arrangement for USA (East Coast)
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Company Overview
Company H1B Sponsorship