The posting
PCS Project Manager
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Responsibilities include: - 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. - 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
