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TriNetX is the Global Health Research Network for Healthcare Organizations (HCOs), Biopharma & CROs. We help to optimize clinical research and enable discoveries through the creation of real-world evidence. TriNetX combines real-time access to longitudinal clinical and genomic data with state-of-the-art analytics to answer complex research questions at the speed of thought.
Our customer base, networks, and product offerings are growing rapidly, and we are expanding our Clinical Sciences team with the hiring of a Clinical Services Project Manager/Director (CSPM or CSPD). Reporting to the VP of Clinical Sciences, this person will need to draw upon their expertise across the areas of clinical research, study design, and project execution to help both TriNetX and our clients meet their goals with respect to clinical trial optimization and real-world evidence generation through the conduct and delivery of chart reviews, patient registries, synthetic control arms, digital trials, and dynamic prospective cohort studies.
The CSPM/CSPD will aid in the development of proposals for customized, fit-for-purpose clinical and real-world data projects, manage all aspects of awarded projects such as timelines, budgets, and conduct, receipt, and transfer of project deliverables to internal stakeholders and project sponsors. The CPSM/CSPD will also learn the TriNetX platform, data, and tools while utilizing his/her existing clinical, organizational, and research skills to aid in the discovery of new approaches to conduct more efficient clinical trials and answer challenging healthcare research questions using real-world data. The ideal candidate will have a thorough understanding of one or more of the following: drug development, clinical trial operations, use of real-world data in healthcare settings, healthcare coding, and epidemiology/outcomes research study design and methods.
Essential Tasks and Responsibilities
- Manage all aspects of small-to-large scale research studies including but not limited to: chart reviews, patient registries, synthetic control arms, digital trials, and dynamic prospective cohort studies.
- Assist in development of study proposals and study tools (e.g. tracking forms, questionnaires, chart review forms, etc.)
- Develop and implement study protocols/operation manuals
- Monitor progress of study activities (e.g. data collection and validation, virtual recruitment, pilot studies, feasibility assessments) and ensure study objectives are met
- Prepare study progress reports independently and/or collaboratively
- Negotiate and manage time commitments and resources, among internal staff, clients, and collaborators/vendors
- Interface with central and local IRBs and potentially assists with IRB submissions, amendments, continuing reviews, etc.
- Prepare, manage and balance project budgets, and seeks cost-effective ways to manage study resources
- Contribute to customer engagements using effective workload management and prioritization capabilities
- Assure data quality, integrity, and confidentiality of information
- Participate in the demonstration of the TriNetX data and platform offerings and capabilities to prospective and new clients
- May co-author scientific papers with colleagues, collaborators, and clients for presentation and/or publication
- Create professional proposals and presentations for internal and external meetings
- Responsible for coordinating all aspects of clinical research studies with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies
- The position is based in Cambridge, MA with telecommuting as a potential option, yet local candidates are preferred.
- Travel component is approximately 5-20%
Required Skills and Experience
- Bachelor's degree in a science or health-related field or an equivalent combination of education and experience with preference to advanced degrees
- 5+ years experience in healthcare, real-world evidence generation, clinical research, clinical trial design, or study feasibility, preferably in a pharma, CRO, data vendor, healthcare, or research setting
- In-depth knowledge in the areas of clinical research, clinical trial design, patient eligibility criteria, and clinical study execution
- Experience in the uses of healthcare and patient data including clinical information systems, EMR, claims, epidemiology sources, etc.
- Strong familiarity with clinical data coding systems and/or computer-based clinical search tools and data analytics
- Significant experience interacting with customers to gather and understand their business/technical/clinical needs and offer well-thought, data-driven solutions
- Established ability to deliver technical and clinical information in a clear concise manner with excellent communication skills on verbal, written and presentation levels
- Demonstrates time management, attention to detail, and organization of workload to handle competing priorities and consistently meet deadlines
- Self-starter who can work independently as well as part of a diverse team
- Position level will be determined by candidate's experience