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Click here or scroll down to respond to this candidateCandidate's Name
West Chester, PA Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLE LINKEDIN LINK AVAILABLEPROFESSIONAL SUMMARYResults-oriented Clinical Operations Manager with a proven track record of success in the pharmaceutical industry. Experienced in employee coaching, onboarding, training, performance management, development of initiatives, and team processes. Leadership duties include multiple clinical trial operations tasks from study execution to closeout. Adept at fostering cross-functional collaboration with leaders and third-party clients to drive process improvements, exceed project, and goal metrics.SKILLS & PROFICIENCIESPerformance Management Project Management Clinical Trials Oncology Clinical Operations Management IIS Studies Database Management IKPI Management Start-up Management Interviewing Training and Development Meeting Facilitation Process Improvement Data Analysis Technical Writing Clinical Trial Support Oncology Studies Drug Ordering Stakeholder Communication Vendor Management SOP Compliance CTMS Veeva SharePoint eTMF Management Microsoft Office Suite Pivot TablesPROFESSIONAL EXPERIENCEICON, PLC (Formerly PRA Health Sciences), Blue Bell, PA 08/2008 05/2024Manager, Clinical Operations (02/2020 05/2024)Supported Investigator Initiated Studies (IIS) for Medical Affairs Oncology group and managed 10-15 direct reports.Assisted in implementation of client onboarding plan for new hires by reviewing metrics with new employees from day one (1) to one-year anniversary.Ensured direct reports met clients quality standards via a biweekly review in accordance with ICON employee performance standards.Evaluated utilization of resources for team collaborating with Director, Managers, and client on assignments for Clinical Study Associates (CSA), Clinical Study Specialists (CSS), and Clinical Study Managers (CSM) functions.Provided oversight of career development goals for up to ten to fifteen direct reports.Conducted new hire interviews and consulted with ICON Talent Acquisition Managers as part of the hiring process.Led leadership meetings with team leads biweekly and rotated weekly Functional Manager meetings weekly for client. Prepared agendas, minutes, and resolved action items.Managed contractual KPIs such as database errors and training for new hires within 90 days of onboarding date.Reconciled training for forty-three (43) ICON IIS team and ensured the metrics for training compliance were > 99%.Co-hosted Bi-Annual Face-to-Face meetings with client and team. Coordinated agenda, minutes, and slide presentations with four (4) Functional Managers.Generated business processes and work instructions for IIS program. Ensured roles and objectives were clearly outlined for IIS team and client.Provided support for CAPA / audit responses and informed ICON Director, Managers, and client of findings.Sr. Clinical Team Manager (07/2018 02/2020)Promoted to Sr. Clinical Manager for IIS Studies in the Medical Affairs Oncology group as Lead of eight Clinical Study Associates.Appointed Sr. Clinical Team Manager and point of contact for eight CSAs on client and study related issues.Developed and updated onboarding processes, training, mentoring and transition checklist forms for new hires.Led CSA monthly meetings to disseminate important program information from client to CSAs on team. Provided leadership, oversight and updates on program objectives, expectations, metrics and timelines.Maintained TMF repository to ensure consistency with latest templates, forms, checklists, and processes.Managed decommission of Livelink repository to ensure processes/check were completed by CSAs.Participated in the interview process for new hires and consulted with Talent Acquisition.Candidate's Name PHONE NUMBER AVAILABLE EMAIL AVAILABLE Page 2Assisted Functional Managers (FMs) with program initiatives. Contributed to ad hoc projects such as writing of the clients Supported Research Manual (GSRM), QC Review of study files, and other program tasks.Managed the National Cancer Institute studies (70+ studies) and the MD Anderson Collaborative studies from start-up to closeout (10 studies).Assisted Functional Managers (FMs) with program initiatives. Contributed to ad hoc projects such as writing of the clients Supported Research Manual (GSRM), QC Review of study files, and other program tasks.Managed the National Cancer Institute studies (70+ studies) and the MD Anderson Collaborative studies from start-up to closeout (10 studies).Clinical Team Manager (07/2017 07/2018)Managed IIS Studies for Medical Affairs Oncology group as Clinical Team Manager supporting Clinical Study Associates (CSAs).Mentored eight CSA colleagues in all aspects of study tasks from start-up to close-out responsibilities.Onboarded new CSAs onto the IIS program and created a CSA Process Checklist document for new hires.Acted as a liaison between client and CSAs disseminating important study information. Held CSA Team meetings monthly disseminating information from client.Carried full workload of 70+ studies for the National Cancer Institute (NCI) and ten (10) studies for MDACC across many therapeutic areas in addition to lead activities.In-House CRA (04/2011 07/2017)Supported sponsored and investigator initiative study teams from start-up through close out.Supported clients Oncology Phase I, II, and III Investigator Initiated Supported studies and managed forty-five (45) countries across four hundred (400) sites. Reviewed study packets consisting of new proposals / protocols for completeness. Sent study start-up and activation packets to new investigators.Generated CTMS accounts and entered all pertinent milestones, study information, and other trial information.Attended Scientific Review Team Meetings and prepared agenda and minutes.Requested study contracts and liaised with contract managers concerning contract status from initial execution to start-up. Collaborated extensively with vendors tracking drug and ancillary supplies.Managed commission of the repository TMF database known as Livelink reconciling queries and other findings.Ran data reports daily for Clinical Trial Manager(s) updating the overall study statuses for these countries / sites.Maintained large and complex data spreadsheet for IVRS Access for internal and external colleagues > 2000 users managing data across numerous studies using Excel using pivot tables.Clinical Trial Specialist (08/2008 04/2011)Supported Hepatology Phase III study in all aspects of study start-up, maintenance, and closeout activities.Created study-specific informed consent templates requesting language translations, as necessary.Prepared files for QA and FDA audits in partnership with CRAs.Collaborated with clinical supplies coordinator in ordering, packaging, and delivery of study drug to investigator sites.Reviewed ongoing data reports and study specific listings from sites, generated queries, and worked closely with Clinical Data Management Team. Prepared for database lock prior to study conclusion.Coordinated Data Monitoring Meetings also collaborating with Clinical Program Manager in writing of the Data Monitoring Plan. Wrote and prepared Data Management Plan.Ensured all protocol deviations for studies were entered into the database InForm. Kept extensive spreadsheet of protocol deviations and communicated with study team members and CRAs as appropriate.Generated program quarterly newsletter.Wyeth Pharmaceuticals (Now Pfizer). 19 years in Research and Development in various roles: Clinical Trial Specialist, Secretary, Executive Secretary, Clinical ScientistEducation: Graduated 2000: B.A., Business Management and Communications, Rosemont College,Rosemont, PA (Graduated Cum Laude)THERAPEUTIC AREA EXPERIENCE: Cardiovascular, CNS, GI & Metabolism, Infectious Disease,Oncology, Hepatology, Hematology and Vaccines. |
