Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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We have an exciting opportunity to join our best-in-class Digital & Decentralized Solutions department. PPD pioneers digital capabilities and deploys solutions to streamline protocols, putting patient experience at the center of every design. We offer services in Telemedicine, Direct to/from Patient models, Remote eConsent, Home Health Care & Nursing, eCOA and ePRO solutions, Mobile sites, Remote Monitoring and Device & Wearables.
The eCOA Project Manager (known as a Digital Implementation Manager (level 2 or 3 at PPD) is responsible for the technical and operational aspects of the electronic clinical outcomes assessments (eCOA) and digital enablement (DE) projects, to achieve the successful completion of eClinical software builds for our clients.
In this role, you will serve as the liaison between the client and PPD to facilitate the flow of information and provide the client with project updates. You will coordinate activities of all PPD functional departments (data management, clinical programmers, testers, global clinical supplies, etc.) and external vendors (translation, technology, copyright holders, etc.) involved in the project.
Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented.
- Works to ensure all project deliverables meet the customer's time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing
- Coordinates activities of all functional departments (data management, clinical programmers, testers, global clinical supplies, etc.) and vendors (translation, technology, copyright holders, etc.) involved in the project.
- Works with team and management to develop plans/guidelines and test scripts for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables. Works with team to identify potential risks, develop contingency plans.
- Acts as principal liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work.
- Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar pass-throughs.
- Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with Project Management Director to provide details for the development and negotiation of contract modifications, as needed.
- Ensures that appropriate training needs are occurring for the team members as needed.
The ideal candidate will have knowledge of the software development lifecycle and clinical outcomes assessments (COAs) including the development, validation, translation and migration (paper to electronic) process. You will have the ability to independently scope eCOA implementation projects and develop project plans and software requirements documents.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years' for level 2 and 8+ years' for level 3).
- Knowledge of clinical outcomes assessments (COAs) including the development, validation, translation and migration (paper to electronic) process.
- Ability to independently scope eCOA implementations projects and develop projects plans and software requirements documents
- In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Knowledge of the software development lifecycle
- Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Solid financial acumen.
- Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.
- Displays effective communication skills (listening, oral, written) and can communicate in English language (oral,written).
- Sound interpersonal skills, is flexible and adapts to changing situations.
- Has the ability to persuade, convince, and influence or impress others.
- Is organized, proficient at multi-tasking with good attention to detail.
- Able to delegate, effectively prioritizes own and workload of project team members.
- Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Possesses cross cultural awareness and is able to adapt appropriately.
- Has experience with leading, liaising and coordinating cross-functional project teams.
- Has knowledge/understanding of clinical development guidelines and directives.
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require minimal as-needed travel (0-20%).