Description
Single Sponsor Associate Clinical Project Director (Program Manager) - 3 days in the Dublin office
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
Core Responsibilities:
Project Leadership and Delivery:
- Manages a project as a Project Manager overseeing interdisciplinary clinical research studies and/or programs and ensures compliance with GCP, relevant SOP’s and regulatory requirements.
- Acts as primary liaison and/or facilitator between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
- Leads project team to ensure quality, timelines and budget management.
- Implements resource strategies to achieve project goals.
- Accountable for all project deliverables for assigned projects.
- Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Identifies and implements performance improvement and operational efficiencies.
Reporting and Communication:
- Maintains and evaluates project progress by maintaining timelines, project plans and other tracking/analysis tools.
- Produces and distributes status, resourcing, and tracking reports as well as functional area plan to customers, appropriate team members and senior management.
- Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication.
- Attends and presents information at internal and external project meetings.
Business Development:
- Develops strong relationships with current and prospective clients to generate new and/or addon business for the future.
- Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
- Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.
Project Administration:
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for the financial performance of each project assignment.
- Accountable for all project deliverables for each project assigned.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
Therapeutic Mastery:
- Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff.
- Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.
Management:
- Serves as team leader and line manages and mentors other project management and clinical monitoring staff.
- Facilitates team building and communication.
- Ability to successfully deliver a project through successful delegation and oversight of project and functional leads.
Job requirements:
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
- Ideally Project Management qualified i.e. Prince II or PMP / equivalent.
- Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
- Strong organizational and time management skills.
- Clinical research organization (CRO) and relevant therapeutic experience preferred
- Ability to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
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.
Summary
The position is responsible for managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol and global projects across various phases and functional areas with limited interaction from supervisor. Accountable for the management of cross-functional resources, tasks, risk management, and quality. The Associate Project Director may contribute to the development of the operational strategy for new business opportunities at the project level. Responsible for mentoring less experienced Project Managers (PMs) and line management responsibilities.
