Heather-Rae Kennedy

Heather-Rae Kennedy Email and Phone Number

Senior Director, Clinical Operations @ ICON plc
Rochester, NY, US
Heather-Rae Kennedy's Location
Rochester, New York, United States, United States
Heather-Rae Kennedy's Contact Details

Heather-Rae Kennedy work email

Heather-Rae Kennedy personal email

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About Heather-Rae Kennedy

Clinical Research professional with over 15 years of experience in both Pharmaceuticals and Medical Devices. Comprehensive knowledge and experience in early to late phase clinical trial management in several therapeutic areas including cardiovascular, imaging, neurology, oncology, psychiatry and sleep medicine. Key areas of expertise include project life cycle management: identifying requirements, planning, implementation, monitoring and successful completion of clinical research activities in accordance with GCP regulatory requirements.

Heather-Rae Kennedy's Current Company Details
ICON plc

Icon Plc

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Senior Director, Clinical Operations
Rochester, NY, US
Website:
iconplc.com
Employees:
33970
Heather-Rae Kennedy Work Experience Details
  • Icon Plc
    Senior Director, Clinical Operations
    Icon Plc
    Rochester, Ny, Us
  • Biotel Research, A Philips Company
    Strategic Alliance Director
    Biotel Research, A Philips Company Feb 2021 - Present
    Rochester, New York, United States
    • Lead for Strategic Alliance relationships intended to expand BioTel Research’s offerings and accelerate its business growth• Manage a portfolio of existing external vendors, including products and services that support internal infrastructure, sales and operations for clinical trials• Manage the procurement of external vendors, including sourcing, requests for information, requests for proposal, evaluation and selection• Plan, define and prioritize key productive strategic alliances • Coordinate contract process in collaboration with Finance and Legal• Manage and achieve savings targets by proactively seeking new opportunities and/or optimizing current agreements to drive efficiency and cost savings• Oversee vendor performance and risk management via establishing, maintaining, reporting objective performance metrics• Work closely with Product Management and Technical Operations during new product launch to take over any vendor or alliance discussions, negotiations and setup• Regularly present to executive leadership on vendor updates and alliance statuses • Maintain knowledge of industry trends and developments to better satisfy business partners needs and goals• Build and maintain strong relationships with internal stakeholders to understand business needs and identify opportunities• Collaboratively connect and message vendor solutions within team• Continually research to understand the company’s operations needs and requirements, industry, and market trends, as well as best practices in order to positively contribute to improvements and productivity
  • Biotelemetry Healthcare, Formerly Cardionet/Mednet
    Global Operations Account Manager
    Biotelemetry Healthcare, Formerly Cardionet/Mednet Aug 2018 - Feb 2021
    Rochester, New York Area
    Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork and communicating in an open, balanced and objective manner Responsible for the operational and relationship management of key accounts.Provide strategic and tactical management and leadership to senior project managers and project managers and cross-functional teams to ensure projects proceed on schedule and comply with operational standards for key accounts Tactical oversight of project start up, ongoing client satisfaction and project performance. Optimizes efficiencies across key accounts Provides input for decisions regarding personnel resources for new and/or existing projects Represent Project Management at Business Development Meetings, Client Meetings, etc. Review and approval of outgoing budgets, proposals and change requests to ensure there is proper financial coverage, consistency, and process descriptions Monitor gross margins on assigned sponsor programs; responsible for reporting margin variances at the time of proposal and actuals Manage strategic operational client relationships and help increase customer loyalty Report on sponsor and MCC metrics to both sponsors and VS internal management Report on project status and relationship management on key accounts to Executive team at a standard frequency Create a detailed customer dashboard that includes metrics and both current and historic project status First point of escalation for the assigned key accounts
  • Virtualscopics, Inc (Now Part Of Biotelemetry Research)
    Manager Of Project Management
    Virtualscopics, Inc (Now Part Of Biotelemetry Research) Aug 2017 - Aug 2018
    Rochester, New York Area
  • Virtualscopics, Inc (Now Part Of Biotelemetry Research)
    Senior Project Manager
    Virtualscopics, Inc (Now Part Of Biotelemetry Research) May 2016 - Aug 2017
    Linden Oaks, Rochester, New York
    • Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork and communicating in an open, balanced and objective manner• Ensure project management operations are compliant with company SOPs and policies• Provide strategic, tactical management and leadership to ensure project milestones are achieved schedule• Optimizes efficiencies and maintaining continuity across project teams• Monitor capacity limitations regarding personnel resources for new and/or existing projects• Represent Project Management at Business Development Meetings, Client Meetings, etc• Review of project budgets and contract amendments to ensure proper allocation • Signatory for any Project Management forms requiring authorization/approval• Oversee Project Kick-offs and guide the Project Manager through the start up process • Manage strategic client relationships• Gather departmental metrics and report them to the Managers of Project Management• Main point of escalation for all projects
  • Virtualscopics
    Project Manager Ii
    Virtualscopics Nov 2014 - May 2016
    Linden Oaks, Rochester, New York
    • Act as the primary contact with the client from startup through close-out of a project with minimal supervision and oversight • Implementation of project plans as scheduled, escalating issues as appropriate to ensure that commitment dates are achieved• Responsible for revenue tracking of ongoing projects, including forecasting for the current calendar year• Provide leadership to cross-functional internal team to ensure efficient processing of project requirements• Conduct routine teleconferences with clients to ensure timely communication of status, issues, and response to change requests• Compliance with all documented procedures ensuring accurate documentation of project activities, decisions, changes, and budgets• Manage custom database with project specific site information and details specific to outstanding issues.• Follow-up regarding site specific data queries including missing data and data holds. • Responsible for implementing and documenting standard work practices associated with the management of projects.• Develop presentations for Investigator Meetings and Kick Off Meetings and travel independently when required. • Travel with Business Development for client meetings
  • Research Dynamics Consulting Group. Ltd.
    Site Manager
    Research Dynamics Consulting Group. Ltd. Jun 2011 - Oct 2014
    Pittsford, New York
    • Responsible for managing the technical and administrative aspects of assigned projects at investigator sites to Sponsor and Research Dynamics specifications• Ensures the project meets contractual and protocol specifications including time, scope and quality. • Develops project-specific training instructions for sites. • Follows up on monitor site activities to ensure all action items from monitoring reports and monitor discussions are completed. • Conduct regular phone calls with the sites/sponsor to ensure protocol compliance and proper patient enrollment rate. • Respond to site phone calls as necessary and prepare written summaries. • Act as an EDC help desk to assist site staff in completing eCRF forms. • Review all initial and ongoing site regulatory documents ensuring accuracy and quality. • Assist with IRB submissions. • Conducts the site pre-qualification phone call and prepares report. • Develops any necessary project team forms and tracking tools. • Ensures that CTMS system and other project documents for patient enrollment, updates, study file checklists, study milestone reports, investigator lists, etc. are accurate and up to date. • Provides timeline projections on patient enrollment, study completion, study milestones, etc. as requested/required. • Attends professional meetings and training workshops to develop and/or maintain current knowledge and to develop and/or maintain effective management skills.
  • University Of Rochester
    Clinical Research Coordinator
    University Of Rochester Feb 2005 - Oct 2014
    Rochester, New York
    Primary Duties: Oversee coordinating of all studies within the lab, oversee all regulatory paperwork and requirements for the lab, primary coordinator on typically 2-5 studies, back-up coordinator on 1-2 studies, oversee subject recruitment for all studies within lab, administer consent form, conduct subject evaluations, train staff on study procedures and protocols Clinical Trial Work: Worked on >10 clinical trials, attended 5 investigator training meetings, created study budgets with sponsors, worked directly with local IRB and WIRB (including completing all submission paperwork and amendments), very proficient in completing CRF documents accurately, online data capture (including Inform & Phase Forward), hosted many study monitor visits and prepared study subject information for audit and monitoring (internal, sponsor and FDA), specimen collection, processing and shipment, drug accountability and knowledgeable of GCP guidelines, FDA regulations and ICH procedures. NIH Funded Grants: Worked on >7 NIH funded studies. Duties included grant preparation & submission, JIT paperwork, creating source documents for data capture, planning logistics of study flow and subject visits, working directly with RSRB for study approvals, carrying out study protocol, and close out/storage procedures Additional duties: Oversee all advertising efforts for the lab; this includes extensive relationships with the Democrat and Chronicle, CITY news, TV ADS, and WXXI Radio. I have played a major role in creating advertisements, managing advertisement budgets, as well as creating and working at many table presentations for health fairs and information sessions. Consultant Work: have worked as a consultant on several occasions with outside investigators creating study budgets, grant preparation & submission, study start up procedures, IRB paperwork and submission, regulatory affairs, manuscript editing & reviews and clinical trial paperwork.
  • University Of Rochester
    Case Manager
    University Of Rochester Jan 2003 - Feb 2005
    Comprehensive Psychiatric Emergency Program Rochester, New York
    Primary Duties: Direct patient care, prepared quarterly statistics for restraint and code red hours, maintained safety logs, phlebotomy, violence & suicide assessment, insurance precertification for admission, and discharge planning.
  • University Of Rochester
    Psychiatric Technician
    University Of Rochester Nov 2001 - Jan 2003
    Child And Adolescent Psychiatric Inpatient Unit
    Primary Duties: Direct patient care, daily SOAP notes, CBT & group therapy, milieu management, training in patient restraint and vital signs.

Heather-Rae Kennedy Skills

Clinical Trials Clinical Research Clinical Monitoring Gcp Ctms Edc Pharmaceutical Industry Cro Data Analysis Management Statistics Neuroscience Oncology Lifesciences Clinical Development Healthcare Spss Psychology Customer Service Medical Devices Leadership U.s. Food And Drug Administration

Heather-Rae Kennedy Education Details

Frequently Asked Questions about Heather-Rae Kennedy

What company does Heather-Rae Kennedy work for?

Heather-Rae Kennedy works for Icon Plc

What is Heather-Rae Kennedy's role at the current company?

Heather-Rae Kennedy's current role is Senior Director, Clinical Operations.

What is Heather-Rae Kennedy's email address?

Heather-Rae Kennedy's email address is he****@****ail.com

What is Heather-Rae Kennedy's direct phone number?

Heather-Rae Kennedy's direct phone number is +158575*****

What schools did Heather-Rae Kennedy attend?

Heather-Rae Kennedy attended Suny Potsdam, Lisbon Central School.

What are some of Heather-Rae Kennedy's interests?

Heather-Rae Kennedy has interest in Children, Education, Science And Technology, Human Rights, Arts And Culture, Health.

What skills is Heather-Rae Kennedy known for?

Heather-Rae Kennedy has skills like Clinical Trials, Clinical Research, Clinical Monitoring, Gcp, Ctms, Edc, Pharmaceutical Industry, Cro, Data Analysis, Management, Statistics, Neuroscience.

Who are Heather-Rae Kennedy's colleagues?

Heather-Rae Kennedy's colleagues are Klea Metschke, Janet Hall, Felipe Delfino Ríos Valdez, John Watson, Supriya Shende, Dallas Grubb, Adrienne Miller.

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