Job Description
Senior eCOA Digital Implementation Manager (remote US)
United States
About the Department:
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.
About the Position:
The Senior eCOA Digital Implementation Manager (level 2 or 3) 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.
Job Description:
- 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. He/she 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 eCOA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’ for level 2 and 8+ years’ for level III) or equivalent combination of education, training, & experience.
- 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
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.
The salary range estimated for these positions is $100,000 – $145,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
- A choice of national medical and dental plans, and a national vision plan
- A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
- Tax-advantaged savings and spending accounts and commuter benefits
- Employee assistance program
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan