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clinical project manager ii resume example with 7+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary

Senior clinical operations and project management professional with 8 years of biotech and pharmaceutical industry experience; 5 years in clinical project management.

  • Demonstrated track record of maximizing business opportunities, providing input to product development strategies, and driving creative end-to-end solutions to operational challenges.
  • Expert at meeting tight deadlines, driving business opportunities and working well in team-based environments. Engaging and personable to manage key milestones and deliver exemplary customer service.
  • Extensive knowledge in consumer experience, project planning, management, and financial reporting. Familiar with fiscal management systems and human resource management.
  • Managed Phase I, II, III, and IV Pharmacokinetics/ Pharmacodynamics, dose ranging, and bioequivalence commitment studies
  • Therapeutic area experience in dermatology, gastroenterology, infectious diseases, neurology, immunology, and oncology.
Education
The Ohio State University Columbus, OH, Expected in 01/2018 Master of Science : Clinical Research - GPA :
Trinity College Hartford, CT Expected in 05/2015 Bachelor of Science : Neuroscience - GPA :
  • Study Abroad: Paris, French Language and Cultural Studies Minor
Skills
  • MS Office (Word, Excel, Powerpoint, MS Project)
  • G-Suite (Gmail, Docs, Sheets, Slides, Drive, Forms, Calendar)
  • eCTMS: Florence eTMF, Medrio, RealTime-CTMS
  • Project planning and management
  • CRO/Vendor management
  • Clinical Development and Risk management
  • Startup Experience
  • Strategy and Operations
  • Reporting and KPI Development
  • Critical Thinking/Problem Solving
  • Process Design and Implementation
  • Team Management
Accomplishments
  • Successfully executed two Phase III pivotal trials (1020 subjects across 115 sites) and locked database 2 weeks post Last Patient Out to meet advanced timelines for New Drug Application (NDA) submission.
  • Led clinical operations team and prepared sites for Sponsor and FDA audits during inspection of Phase IIa/IIb project and received positive feedback from Sponsor VP of QA, initiated and completed resolutions to findings, and managed CAPAs.
  • Successfully accelerated timelines for a Phase III study in order to maintain project objective despite added complexities in study design after CTO/protocol finalization
  • Delivered a revised and Protocol Review Committee approved protocol after a Regulatory decision to include the document in the FDA briefing package with only 4 weeks notice. First Patient In (FPI) achieved only 2 months after contract award.
  • Developed and executed recruitment contingencies to successfully mitigate difficult enrollment of severe cholestatic/uremic pruritus patients without compromising project timelines.
  • Managed largest off-label study in women's health trial (4 arms, 1500 subjects) . Start-up activities completed within 4 months, after FPI was shifted 1 month earlier to fast track NDA submission
  • Developed data batch cleaning timelines to be utilized by Clinical Operations as a standard in mid- to large sized studies to reduce QA risks and database lock timeframes.
  • Authored Study Start-up, Conduct, and Closeout SOPs in collaboration with Director of Clinical Operations to be used as a company standard for all Project Managers.
Work History
Hca - Clinical Project Manager II
Highlands, NC, 08/2021 - Current
  • Served as Clinical Project Manager (CPM) for various US and global clinical trials
  • Ensured study team operated within scope, budget and timelines and mitigated deviations to project objectives
  • Manage project contractual deliverables: supervises progress via metrics (time, quality/scope and cost); leads presentations of internal project status reviews. proactively identifies, resolves/mitigates and escalates risks and/or issues.
  • Manages project costs: owns projections of units/hours and actual analysis; identifies, negotiates and executes contract modifications, identifies potential or actual unrecoverable hours and provides analysis and mitigation /resolution plan for senior management.
  • Led project workshop (pre- and post study activation) and presented plan for implementing lessons learned to improve efficiencies for overall study execution
  • Developed strategy and obtained cross-functional buy-in for plan to optimize activities and resources due to overlapping study end timelines for pivotal studies
  • Acts as primary point of contact between Science 37, third-party vendors, CRO(s) and study Sponsor project team
  • Tracked financial expenses and worked in collaboration with Contracts Group to perform periodic reconciliation of contracts
  • Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks
  • Coordinate assignments of resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget
  • Primary author of study project plan, in conjunction with the Director of Clinical Operations, and sponsor representative(s), outlining target KPIs, risk assessment, and contingency planning
  • Effectively led team to present organizational changes to project management to help streamline activities across studies, look for ways to reduce/optimize costs, and to present additional recruitment contingencies
  • Developed robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning for study lifecycle
  • Successfully completed protocol amendment, CRO Work Order execution, and study start up activities including CRO KOM and site feasibility for Phase II cholestatic/uremic pruritus study in 2 month timeframe to accommodate late management decision to accelerate FPI target by 5 months
  • Mentored junior CPMs and lead biweekly PM Open Forums
  • Led internal and external cross-functional team leaders and third parties/vendors: guides team leads in prioritizing, trouble-shooting and contingency planning; liaises with functional lead/managers to optimize performance and utilization of project team members.
  • Led Vendor Management for all third-party vendors and executed contracts and maintained communication throughout project lifecycle.
  • Presented project status during monthly Clinical Trial Project Review meetings as needed.
Dartmouth College - Clinical Operations Manager
Hanover, NH, 02/2019 - 07/2021
  • Responsible for driving value-based care initiatives and managing day-to-day clinical operations for startup company, including management of stakeholders and coordination of patient care.
  • Analyze financial and operational data to uncover performance issues and lead execution of process improvements. Provide strong strategic guidance to ensure product-market fit and opportunities to scale.
  • Develop and routinely update clinical management work- plans/programs to ensure revenue accuracy and optimal care delivery.
  • Identified opportunities to improve clinical practices, devised strategies and in collaboration with Chief Medical Officer, implemented plans to increase patient care standards and enhance operational procedures.
  • Developed SOPs for Patient Care Department and facilitated hiring of qualified Care Coordinators by interviewing applicants and making recommendations for employment.
  • Implemented onboarding for new employees, which enabled each to effectively learn tasks and job duties.
  • Managed team of 10 care coordinators to ensure optimal patient care delivery.
  • Regularly evaluated employee performance and provided feedback.
  • Build team infrastructure using systems like JIRA ensure scalability with company growth.
  • Reviewed financial resources and prepared reports showing resource allocations.
  • Established budget, timelines, and detailed planning for departmental goals for patient care operations and took appropriate actions to limit any variances
  • Led departmental team discussions during regular all-hands meetings
  • Partnered with diverse, C-suite clientele to customize product design and implement patient programs, resulting in satisfaction and higher patient engagement in 90th percentile.
  • Maintained cross-functional account management for up to 10 accounts simultaneously to implement suite of 4 different patient experience products.
  • In collaboration with Patient Acquisition Manager, devised patient acquisition plan detailing potential obstacles and contingencies
  • Implemented 5 process improvement initiates to support acquisition and patient engagement leading to increase in patient conversion by 30% and retention by 15%.
  • Developed and implemented procedures to improve and automate the screening process for clinical trials within Emilie Scientific. - Supervised and coordinated mono- and multi-center clinical trials to ensure observational study design and conduct were in line with internal SOPs, GCP, and local regulations - Worked to translate recruitment, retention and site engagement strategies into operational plans to positively impact recruitment and retention rates. - Presented study status at monthly meetings - Worked to translate recruitment, retention and site engagement strategies into operational plans to positively impact recruitment and retention rates.
Highmark Inc. - Senior Research Project Manager
Harrisburg, PA, 04/2018 - 02/2019
  • Effectively coordinated study management and trial activities for several Phase II and III oncology study after assuming responsibilities during study Director's leave of absence
  • Ensure regulatory compliance with FDA, ICH and GCPs; ensures non-regulatory compliance with study documents; developed project plans to meet study deliverables
  • Establish enrollment protocols and worked to meet projections across 8 managed sites.
  • Manage all components of clinical trials from protocol inception through final deliverable; including but not limited to staffing; writing and implementing protocols; site selection; Informed Consent Form and CRF development; monitoring plans and training site staff.
  • Evaluate workload, quality and budget metrics through regular review and report findings and process improvement initiatives to stakeholders
  • Assisted Principal Investigator with managing trial sites, CRO, and laboratory for Acute Myeloid Leukemia studies and met/exceeded milestones
  • Worked closely with radiologist and oncologist to ensure appropriate interpretation of image review is conducted per protocol required oncology reading criteria
  • Maintained study budget and generation of monthly invoice tracking and identifying relevant change of scopes from original budget and contract
  • Functioned as team lead for site selection process and provided final list of potential investigators to Director of Feasibility ; Experience with conducting feasibility/pre-study visits in Canada and United Kingdom
  • Assisted in coordination and organization of technical training and conducted presentations at Kick-off meetings, Investigator meetings, CRO/CRA training meetings
  • Managed, tracked and documented CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency and duration, and conducting co-monitoring visits; Reported site status, significant protocol deviations and issues to study Director with proposed resolutions
  • Tracked subject enrollment and retention and collaborated with CTA to identify issues, trends, and resolutions
  • Assisted with data query resolution
  • Followed up with CRO and/or sites on lab abnormalities, AEs, SAEs, and pregnancies; Performed SAE reconciliation between the Clinical and Safety databases
  • Generated and tracked milestone payments per Investigator Research Agreement
Wexner Medical Center, The Ohio State University - Clinical Research Coordinator
City, STATE, 01/2016 - 04/2018
  • Monitored Phase I-IV neurology clinical research trials to ensure adherence to study protocol and FDA GCP and ICH guidelines
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Worked with study team to develop, review, and finalize source documents and ICFs
  • Followed informed consent processes and maintained records.
  • Developed monitoring tools to track subject profiles, enrollment, CRFs reviewed/retrieved, protocol deviations, adverse events, and regulatory documents
  • Generated instruction sheets outlining critical study information for trial sites
  • Collaborated with study team and site personnel to complete study start up activities (e.g., obtain study documents, ensure adequate supplies, regulatory submissions etc.)
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Oversight of trial sites including identification/resolution of issues, verification of proper study conduct, and communication of study progress and updates
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Exceeded trial goals and targets, averaging 91% enrollment target and 95% retention rate per assigned protocol
  • Worked with site personnel and Data Management to resolve queries in timely manner
  • Followed up on AEs, SAEs, and pregnancies reported at trial sites
  • Reported progress of trial sites to Project Manager and study team during internal study meetings
  • Gathered, processed, and shipped lab specimens.
  • Prepared and maintained regulatory documents for clinical trial submissions.

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Resume Overview

School Attended

  • The Ohio State University
  • Trinity College

Job Titles Held:

  • Clinical Project Manager II
  • Clinical Operations Manager
  • Senior Research Project Manager
  • Clinical Research Coordinator

Degrees

  • Master of Science
  • Bachelor of Science

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