Hope Leber
Harleysville,PA
Summary
Reliable Manager with a high level of ownership and initiative. Exceptional work ethic and commitment to surpassing company expectations. Skilled in building productive working relationships. Successfully manages goals and team development in fast-paced, deadline-driven environments. Thrives in team-oriented settings.
Overview
28
28
years of professional experience
Work History
Manager, Clinical Data Management
ICON, formerly PRA Health Sciences
Blue Bell, PA
08.2019 - Current
- Covers and provides backup for team Director in their absence.
- Co-leads a team of over 80 employees with 15 or more direct reports.
- Assesses team members' skillsets and assigns tasks accordingly for optimal efficiency.
- Monitors staff performance and addresses issues.
- Holds regular one-on-one meetings with employees to review performance and priorities, and provide feedback.
- Conducts performance evaluations, providing feedback and coaching for team development.
- Provides leadership during times of organizational change or crisis situations.
- Recruits and hires qualified candidates to fill open positions.
- Coaches, mentors, and trains team members in order to improve their job performance.
- Enhances team morale and retention through recognition programs and career development opportunities.
- Resolves conflicts between employees by providing guidance on company policies and procedures.
- Establishes processes to ensure efficient workflow throughout the organization.
- Develops and implements strategies to increase customer satisfaction and loyalty.
- Ensures compliance with all applicable laws, regulations, and industry standards.
- Organizes special events, such as team building events and holiday gatherings, for employees.
- Supervises specialty teams, ensuring efficient SAE and Vendor Reconciliation processes.
- Participates in various company cultural events and micro-community gatherings, such as International Women's Day, to foster stronger connections with colleagues.
Principle Lead Data Manager
PRA Health Sciences
Blue Bell, PA
08.2018 - 08.2019
- Oversight of SAE Reconciliation Team; Subject Matter Expert for SAE Reconciliation Process.
- Takes lead role in managing nine direct reports.
- Oversight of Raw Data Handling group, including Raw Data Downloaders and External Reconciliation Team; Subject Matter Expert (SME) for External Reconciliation Process.
- Provides project performance feedback to employees.
- Interviews potential employee candidates.
- Writes and maintains External Reconciliation and SAE Reconciliation specification reports.
- Interact with various Data Management and other functional area colleagues, including but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, and site personnel.
- Provide assistance, mentoring, and/or training to Clinical Data Management staff, such as Clinical Data Coordinators and/or Clinical Data Managers, as necessary.
- Acts as backup for Associate Director when out of the office.
- Maintained relationships with external vendors providing services related to database management.
- Created procedures for data sharing and managed incoming and outgoing data files.
Senior Lead Data Manager
PRA Health Sciences, formerly RPS
Blue Bell, PA
08.2017 - 08.2018
- Performed data analysis and created reports to identify trends or discrepancies in the data.
- Oversight of SAE Reconciliation Team and Raw Data Handling Team.
- Resolved complex queries by analyzing query plans and optimizing indexes when necessary.
- Assists with vendor reconciliation, such as External Data and Serious Adverse Event reconciliation.
- Responsible for co-writing external reconciliation guideline document.
- Maintained relationships with external vendors providing services related to database management.
- Wrote and maintained reconciliation specification reports for vendor reconciliations.
- Acted as backup for Manager and Associate Director when out of the office.
- Interacted with various Data Management and other functional area colleagues, including, but not limited to, Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, and site personnel.
- Provided project status and employee performance updates to management.
- Provided assistance, mentoring, and/or training to Clinical Data Management staff, such as Clinical Data Coordinators and/or Clinical Data Managers, as necessary.
Lead Data Manager
PRA Health Sciences, formerly RPS
Blue Bell, PA
04.2016 - 07.2017
- Provided training to the team of Clinical Data Management which involved assistance, mentoring, and advice-giving
- Assisted with the maintenance of all relevant documentation associated with each assigned protocol.
- Assisted in various Clinical Data Management production activities, such as data dredging.
- Issued queries within the clinical database for missing, inconsistent, illegible, or erroneous data; followed queries to resolution, and close out.
- Communicated data issues and/or query trends to supervisor.
- Assisted with all clinical data cleaning, including external data cleaning, Serious Adverse Event reconciliation, and taking appropriate action on terms that failed coding.
- Reviewed clinical data as per SOP, protocol, and study-specific guidelines.
- Interacted with various Data Management and other functional area colleagues, including but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, and site personnel.
- Assisted with clinical database close-out activities, including, but not limited to, listing review, audit activities, etc.
- Assisted with study start-up activities, including, but not limited to, testing CRF mock-up and entry, database screen testing, and edit check testing.
Sr. Clinical Data Coordinator
Research Pharmaceutical Services (RPS)
Blue Bell, PA
05.2011 - 03.2016
- Assisted with the maintenance of all relevant documentation associated with each assigned Protocol.
- Communicated data issues and/or query trends to supervisor.
- Assisted with all clinical data cleaning, including, but not limited to: external data cleaning, such as lab review, Serious Adverse Event reconciliation, and took appropriate action on terms that failed coding.
- Provided assistance, mentoring, and/or training to Clinical Data Management staff, such as Clinical Data Coordinators and/or Data Entry staff, as necessary.
- Assisted with clinical database close-out activities, including, but not limited to, listing review, audit activities, etc.
- Interacted with various Data Management and other functional area colleagues, including but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, and site personnel.
- Assisted with any and all Clinical Data Management production activities, including, but not limited to, data dredging activities. Assisted with study start-up activities, including, but not limited to, testing CRF mock-up and entry, database screen testing, and edit check testing.
- Reviewed clinical data as per SOP, protocol, and study-specific guidelines.
- Issued queries within the clinical database for missing, inconsistent, illegible, or erroneous data; followed queries to resolution and closeout.
Clinical Data Coordinator
ICON
North Wales, PA
08.2008 - 04.2011
- Completed Quality reviews and appropriately addressed all related issues.
- Appropriately addressed data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Performed Serious Adverse Event reconciliation in accordance with all applicable procedures.
- Accurately generated data queries to resolve data discrepancies, and appropriately addressed responses to data queries.
- Managed sponsor studies, attended internal/external meetings, and mentored less experienced staff.
Senior Product Release Coordinator
Merck
West Point, PA
12.2007 - 08.2008
- Assisted in managing all aspects of the release process for Varicella Bulk Vaccines.
- Supervised, mentored, recruited, and interviewed new employees.
- Collaborated with personnel in Manufacturing, Technology, Planning, and Quality to resolve issues.
- Facilitated atypical investigations to completion and provided recommended production dispositions and corrective actions where appropriate.
Product Release Coordinator
Merck
West Point, PA
07.2002 - 12.2007
- Prepared and reviewed batch release documentation for VARIVAX, COMVAX, Liquid PedvaxHIB, and GARDASIL.
- Utilized Beckman LIMS, NGL, IMPACT/QRS, and other databases in the control and release of products.
- Performed QRS/IMPACT transactions, reviewed and approved testing data, and completed package identity testing.
Senior Product Release Associate
Merck
West Point, PA
01.2001 - 07.2002
- Provided support to the Sterile Filling Area and Department 945 (MEDEVA).
- Processed manufacturing, laboratory, and sterility investigations, risks, change requests, and rejection and discard notifications.
- Reviewed site master formulas for MMR, VARIVAX, ELSPAR, and BLACK WIDOW SPIDER, ensuring compliance with cGMPs.
Laboratory Technician
Merck
West Point, PA
02.2000 - 01.2001
- Participated in the identity and potency testing of various Varicella samples.
- Performed cell trypsinization and culturing of cells, and macroscopically examined plaque formation of test fluids.
- Performed serological dilutions and titrations, direct cell counts using a hemacytometer, and prepared appropriate culture media.
- Recorded test observations, calculated data, and performed computer analysis by entering test data using LIMS.
Biotechnician
Merck
West Point, PA
11.1998 - 02.2000
- Operated and monitored equipment such as fermentors, kettles, centrifuges, glucose analyzer, pH and conductivity meter.
- Performed in-process tests such as macroscopic and microscopic examination of streaked culture tubes, pH readings, agglutination tests, optical densities, glucose determinations, gram stains, and serological probes.
- Contributed to the fermentation and purification processes of Haemophilus Influenzae and Pneumovax.
Medical Technologist
Doylestown Hospital
Doylestown, PA
06.1996 - 11.1998
- Performed medical laboratory tests, procedures, and analyses to provide data for diagnosis and treatment of disease.
- Conducted chemical analyses of specimens to determine presence of normal and abnormal components.
- Specialized in areas such as Chemistry, Hematology, Blood Bank, Urinalysis, Microbiology, and Phlebotomy.
Education
Master of Science - Quality Assurance/Regulatory Affairs
Temple University
Philadelphia, PA05-2005
Bachelor of Science - Medical Technology
Misericordia University
Dallas, PA05-1997
Skills
- Staff Development
- Strategic Planning
- Staff Training and Development
- Cross-Functional Teamwork
- Team Leadership
- Operations Management
- Policy Implementation
- Performance Management
Accomplishments
- Icon Inspire Award - Amazing Efforts for Participation in IWD Blue Bell Event, March 2023
- Icon Inspire Award - Going the Extra Mile to Ensure a Successful Client Meeting, June 2023
- Icon Inspire Award - Amazing Efforts for Participation in Breast Cancer Awareness Month, November 2023
- CDM 'Integrity' Award - Sponsor, November 2017
- CDM 'Humor' Award - Sponsor, February 2017
- Local Knowledge Award (LKA) - PRA, December 2014
- Icon Inspire Award - Contributions for the Blue Bell IWD Event, March 2024.Tier 1 award – RPS, 2011
- Tier 2 award – RPS, 2011
- Award of Excellence 2007
- Award of Excellence 2008
- Profit Plan Coordinator 2007
- Award of Excellence 2002
Therapeutic Area
- Respiratory
- Neurology
- Oncology
- Hematology
- AMKD
Timeline
Manager, Clinical Data Management
ICON, formerly PRA Health Sciences
08.2019 - Current
Principle Lead Data Manager
PRA Health Sciences
08.2018 - 08.2019
Senior Lead Data Manager
PRA Health Sciences, formerly RPS
08.2017 - 08.2018
Lead Data Manager
PRA Health Sciences, formerly RPS
04.2016 - 07.2017
Sr. Clinical Data Coordinator
Research Pharmaceutical Services (RPS)
05.2011 - 03.2016
Clinical Data Coordinator
ICON
08.2008 - 04.2011
Senior Product Release Coordinator
Merck
12.2007 - 08.2008
Product Release Coordinator
Merck
07.2002 - 12.2007
Senior Product Release Associate
Merck
01.2001 - 07.2002
Laboratory Technician
Merck
02.2000 - 01.2001
Biotechnician
Merck
11.1998 - 02.2000
Medical Technologist
Doylestown Hospital
06.1996 - 11.1998
Master of Science - Quality Assurance/Regulatory Affairs
Temple University
Bachelor of Science - Medical Technology
Misericordia University
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