Telehealth Project Manager

Hawkins Point Partners Cambridge , MA 02138

Posted 1 week ago

Hawkins Point Partners has an immediate need on its Lexington Massachusetts team for a Senior Business Analyst/Project Manager to support and integrate new telehealth technology into in process clinical trials. The ideal candidate will have requirements management expereince along with customer service skills. Must be able to execute as a trusted advisor between scientific clinical system users and telehealth technology. Must have a strong vendor management along with EDC-Electronic Data Capture skills. Core to this role will be the ability to Set-up and maintained standardized processes for EDC Build. This person will introduce new telehealth technology into clinical trials. This person will integrate telehealth technology with three clinical trials and scale up to one hundred clinical trials. Ability to create and implement a standardized, documented and repeatable business process-based on user requirements-is key to this role.



  • Strong requirements management/business elicitation skills. Able to execute as a trusted advisor between scientific clinical business community and telehealth software vendors. Vendor Management skills and ability to hold vendors to established timelines and agreed service levels is key.
  • Strong foundation in drug manufacturing clinical tracking skills. Understanding of validated 21 CFR environments, EDC-Electronic Data Capture/ the ability to set-up and maintain a standardized process supporting an EDC build.
  • Expereince and understanding of data capture clinical trial systems along with best business practices of integration with cutting edge telehealth technology. Examples of telehealth technology include secure email, online video conferencing and eVisit telehealth platform. Expertise in cloud data storage is a plus.
  • Core project management skills-write a project charter and schedule, keep a project within scope, track budget, implement best integration practices and establish a standardized documented and repeatable clinical trial integration process in a (21 CFR) validated environment.
  • Bachelor of Science or advanced degree in a related discipline
  • PMP-Project Management Professional Certification is a plus.


At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Project Manager /Senior Clinical Project Manager

Dicerna Pharmaceuticals, Inc.

Posted 5 days ago

VIEW JOBS 5/30/2020 12:00:00 AM 2020-08-28T00:00 Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare diseases, chronic liver diseases, cardiovascular disease, and viral liver infectious diseases. The Company is using its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these therapeutic areas. We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. The CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious liver-targeted disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout. Responsibilities: Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate. Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives. Develop study plan(s) including key milestones and timelines. Ensure country and site selection meet study requirements. Participate in the development and testing of clinical systems (e.g., data capture, IxRS). Ensure internal and external systems are updated in a timely manner (e.g., trackers, Manage critical study documents, such as consent forms, study manuals, subject recruitment materials. Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Drive critical clinical trial activities including trial site activations, recruitment, and database lock. Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally. Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation. Provide input in internal/external study related audits, review resulting reports. Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed. Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Represent Dicerna during site initiation visits, trainings, close out visits, and conduct co-monitoring visits as needed. Train study team members, external monitors, and site staff as needed. Requirements: Bachelor's degree in a scientific discipline is required Minimum of 5 years of clinical development experience in the pharmaceutical industry At least 2 years of experience as a Clinical Trial Manager. For a Senior Clinical Trial Manager, at least 4 - 5 years of experience as a Clinical Trial Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH guidelines, GCP and FDA regulations Experience with all aspects of trial and site startup and vendor management Experience in rare disease, pediatric, and/or complex clinical trials preferred Ability to deal with multiple priorities with aggressive timelines Strong oral and written communication skills Ability to find creative solutions to issues impacting timelines and budgets Willingness to travel up to 10% of the time, both domestically and internationally Dicerna Pharmaceuticals, Inc. Cambridge MA

Telehealth Project Manager

Hawkins Point Partners