Technical Project Manager — Outcome Job in Cambridge 02138, Massachusetts US
**Preferable location is Cambridge, MA**
Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management.
Purpose:
With limited oversight from management, the role is to implement agreed upon strategies for the management of national and international (US/EU/ROW) internet-based outcomes studies with pre-specified timelines and budgets at the project and/or Program level.
Primary Responsibilities:
- Leads Project, Programs or initiatives that may include monitoring, EDC development (production and maintenance), data management, programming, safety, statistics, report/protocol writing, medical affairs and agency presentations and ensure these requirements are properly documented.
- Manages global project goals within Clinical Operations including startup activities focused around site identification, patient recruitment, contract (CTA) and budget, enrollment and monitoring plans, marketing and public relations campaigns as they align to the expectations for the study to adhere to the complex project requirements, deliverables, schedules and budgets.
- Within a matrix environment, oversee all deliverables, milestones and deadlines related to assigned studies/projects, including site enrollment, regulatory and IRB/EC approvals, and patient enrollment and follow-up.
- Provide the Clinical Site Management team with the information and tools needed to ensure their ability to support the program both initially and throughout the project duration.
- Work closely with the cross functional teams (such as Development, Quality Control, Data Management, Statistics) to lead resources during the design, development, testing and implementation of EDC, including answering questions and clarifying requirements for the clinical design and objectives.
- Act as customer advocate throughout the project lifecycle.
- Serve as the liaison between the clients and internal team to ensure project-specific information and ongoing updates are proactively communicated. Assure that meeting minutes and communication of decisions and action items are documented appropriately in minutes.
- Firm understanding the contractual obligations to each client and ensure those responsibilities are met (with the goal to exceed those expectations). Leads the development and review of the proposal and budget to align with the SOW.
- Implement client’s expectations for the study and define project requirements, deliverables, schedules and budgets.
- Identify out-of-scope tasks and client requests per change management and facilitate writing Change Orders that align with Sponsor expectations.
- Provides monthly status reports to sponsor and/or internal purposes, financial reports requirements utilizing corporate reporting tools (PSR Meetings), Invoice Generation and revenue review (ETC and Project Margin), Timesheet review, and pass-through cost review as applicable.
- Guide client through EDC configuration and customization decisions including driving the software features versus cost/schedule trade-off decisions with the client and offer best practices. Ability to understand and offer customization options that align with the technical group's capabilities. This includes managing internal resourcing ageist client timelines and user requirements.
- Proactively identify issues and develop strategies for assuring study timelines are met and assuring quality deliverables. This includes risk management, contingency planning, enrollment strategies and creative "outside the box" thinking.
- Develop, Review and/or maintain clear study related documents, including supporting system specifications that require technical writing. Ensures all critical study documentation (i.e., DMP, Monitoring Plan, SAP, and Training) is collected and filed in TMF/eTMF so that we are audit ready.
- Manage the preparation, maintenance and traceability of central and site files (TMF/eTMF) for projects with the functional leads.
- Adhere to internal change management processes per our internal SOPs, WI and project specific process. Including project specific quality initials to assure that projects are audit ready.
- Identification, coordination and management of external providers/vendors as applicable.
- Participate in the development, review and drafting of proposals and then participate in the bid defense meetings as required.
- Mentor and/or manage project management staff and other team members as applicable.
- This job description may include additional individual duties and responsibilities not listed in detail but still expected to be reasonably performed.
Requirements:
- Master's degree or a Bachelor's degree and equivalent experience.
- 6 or more years of Project Management experience preferably in the health care, medical research, CRO, Pharmaceutical or technology setting.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and understanding of the clinical development process (Phase I-IV, post marketing, abstraction protocols and/or REMS).
- The ability to learn quickly, multi-task and prioritize are essential including the ability to handle multiple projects simultaneously and manage multi-functional teams.
- Must have creative problem solving skills; very strong written, verbal communication skills.
- Demonstrated success in Project Management.
- Ability to travel and attend international meetings.
February 20, 2007
• Tags: Massachusetts Us, Technical Project Manager -- Outcome Job in Cambridge 02138 • Posted in: General