Job Description
Summarized Purpose:
Directs complex strategy, technical, and operational aspects of digital projects that are within scope of award for their own studies and as SME for others.
Essential Functions and Other Job Information:
• Assists in scoping a solution at proposal stage, identifying the best solution(s) for proposals.
• Presents at client bid defense meetings the scope of the digital solution and services.
• Acts as advanced industry wide subject matter expert for digital solutions (design and operational) and services both for internal and external stakeholders.
• Advises on competitive landscape within industry for digital solutions.
• Acts as Oversight Director on studies and programs as required.
• Leads internal process and improvement initiatives.
• Directs the technical and operational aspects of projects.
• Works with major functional area leads to identify and evaluate fundamental issues on the project, interprets data on complex issues.
• Makes sound business decisions and accountable that solutions are implemented and meet the customer's time/quality/cost expectations.
• Coordinates activities of all functional departments (data management, programmers, testers, global clinical supplies, etc.) and vendors (translation, technology, copyright holders, etc.) involved in the project.
• 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.
• Oversees the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with management 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.
Job Complexity:
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Job Knowledge:
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received:
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Business Relationships:
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.
Qualifications:
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 8+ years).
In some cases an equivalency, consisting of a combination 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:
• Expert knowledge of the software development lifecycle
• Expert knowledge of digital solutions and their relevance in clinical research.
• Ability to independently manage and oversee projects and develop all associated plans and documents
• Expert 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 • Ability to persuade, convince, and influence or impress others
• Organized, proficient at multi-tasking with good attention to detail
• Able to lead, 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
• Ability to lead and coordinate cross-functional project teams
• Good knowledge/understanding of clinical development guidelines and directives
• Ability to proactively identify potential risks and mitigation plans across the scope of work for programs, studies, and projects
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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