SUMMARY:

• A motivated, energetic Project Manager professional with extensive experience in achieving business goals, developing materials and improving processes in the competitive pharmaceutical industry.

TECHNICAL SKILLS:

SKILLS: MICROSOFT WORD MICROSOFT EXCEL MICROSOFT PROJECT MICROSOFT ACCESS MICROSOFT POWERPOINT RAVE SQL PHASE FORWARD INFORM ORACLE RDC SHAREPOINT CTMS

PROFESSIONAL EXPERIENCE:

Principal Clinical Data Manager / Manager, Data Management

Confidential

Responsibilities:

• Manage all operational aspects of clinical trials in compliance with GCP regulations. - Review and manage project budgets, timelines and resources across Client programs and studies.
• Ensure and create timelines of deliverables for each phase of the study from study start-up through production and close-out activities.
• Oversee all start-up, maintenance and close-out activities along with UAT
• Act as the Study Manager for one or more studies, responsible for customer contact, functional, administrative and financial oversight for allocated projects.
• Perform the Project Management role for projects without clinical services, or act as a Clinical Data Management Franchise Lead.
• Ensure the set-up activities for a study are performed correctly and in a timely manner.
• Perform study specific and ensure staff are following current procedures.
• Represents Clinical Data Management at internal and external meetings and presentations.
• Travel to and from Investigator Meetings when needed along with requested client meetings and BID Defense.
• Create new Working Procedures and update SOPs when needed.
• Main point of contact for Data Management for the client and vendors being used.
• Review and help create SOW for contract purposes and proposals.
• Oversight of Third Party Vendors
• Oversight of Data Management Leads and Data Reviewers.
• Main point of contact for any Study escalations that may arise.

Trial Manager/PDM — Project Data Manager

Confidential, Blue Bell, PA

Responsibilities:

• Manage all operational aspects of clinical trials in compliance with GCP regulations. - Review and manage project budgets, timelines and resources across Client programs and studies.
• Ensure timelines of deliverables for each phase of the study from study start-up through production and close-out activities.
• Ability to multi-task.
• 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.
• Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol. Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
• Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion for any findings in the INFORM EDC system.
• Participate in study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
• Escalate any potential or actual issues to supervisor, project team, and/or Client Company in a timely manner, and follow issues through resolution.
• Provide written project status reports to Client Company and verbally present as necessary at Client Company meetings.
• Delegate or assist with delegating daily tasks for all protocols to Lead Clinical Data Managers, Clinical Data Managers, and/or Data Entry staff along with external vendors.
• Contribute to the development and/or vision of Clinical Data Management SOPs and related documentation. Assist in establishing metrics for project progress performance, and cost. Assist in evaluating project performance to these standards.
• Serve as primary point of contact for all Client Company project timeline communication. - Assist with resource planning and forecasting.
• Maintain awareness of team members PTO requests, ensuring all deliverables will be maintained.
• Contribute to Annual Employee Performance Evaluations.
• Evaluate and manage project budget against project milestones to ensure project profitability. Tale corrective measures where necessary to keep project in line with budgets and profitability.
• Conduct internal and external team meetings.
• Assist Supervisor with interview and selection process of new staff.
• Work closely with CDM Proposals, Operations, Medical Affairs, Strategic Alliances, Strategic Development, Strategic Operations and Information Services Departments to perform appropriate client, indication and therapeutic area research to support the proposal development and required study change orders.
• Oversee study eCRFs, IVRS and eDiary implementation projects.
• Help utilize and oversee global Data Management Outsourcing and Contracting Projects, Initiatives and Timelines.
• Develop relationships with CROs and oversee projects and maintain deliverable
• Oversee Data Management tasks to deliver all milestones with external vendors.
• Facilitate the translation of documents such as Confidential t diaries, participation cards, etc. with external translation vendors.
• Provide input to new processes and help train new and existing staff members.

Senior Clinical Data Manager

Confidential

Responsibilities:

• Build study sites / investigator relationships in the database and create Confidential t blocks. Assign investigators to Confidential t blocks. May attend and present at the investigator meeting. Oversee handling and resolution of all data discrepancies. Assure accurate DCF content and resolutions from clinical sites, re-querying if necessary. Monitor resolutions of data entry items from workflow problem queue. Review vendor data load. Complete periodic review and quality review of data using the Data Review Plan and tools used to perform quality check. Review data reports and listings for appropriate handling and outliers or potential trends of clinical importance. Accountable for database lock. Verify all data is in the database, all DCFs are returned and validations are resolved through Pune editors. Review and address all CDR (Clinical Data Report) issues. Freeze the database and unfreeze, if necessary, for data modifications. Represent PharmaNet/i3 on assigned clinical teams. Primary contact for Clinical and CTM. Maintain primary responsibility to ensure successful management and completion for CDM portion of the study. Responsible for follow-up of any CDM related issues from the Study Team.
• Ability to multi-task.
• Independently maintain appropriate documentation as required by SOPs. Perform project management activities, including tracking of database design and build completion. Assist in routine operations of data management activities for assigned studies such as clinical team interactions / client support, promoting smooth function of CDM shared services, tracking progress to meet milestones, forecasting resource needs.
• Responsible for metrics reporting and workload forecasting for all assigned therapeutic area studies. May supervise and mentor staff in routine operations of data management activities.
• Participate in review processes including, Safety Review and the Quality Control process for labs. Identify and communicate outstanding critical DCFs. Review DCF responses and update database and/or discrepancy toolset.
• Assist in the identification/resolution of production errors and additions.
• Design DataFlow Diagrams along with Clinical Data Reports and Data Quality Development Plans. Help Train and manage globally located staff. Assist in audits and submission activities for ongoing studies.
• Travel to sites or Investigator Meeting when needed.
• Serve as a liaison between different departments on a Study Team.

Specialist - Clinical Data Project Manager

Confidential, Collegeville, PA

Responsibilities:

• Responsible for metrics reporting and workload forecasting for all assigned therapeutic area studies. May supervise and mentor staff in routine operations of data management activities including: ADD meetings, data validation conducted on-shore or in Bangalore, clinical team interactions / client support, promoting smooth function of CDM.
• Participate in review processes including, Safety Review and the Quality Control process for labs. Identify and communicate outstanding critical DCFs. Review DCF/SDCF responses and update database and/or discrepancy toolset.
• Assist in the identification/resolution of production errors. May assist in resolving issues with workflow admin. - Participate in discussion of the development of new objects based on study requirements.
• Work with therapeutic area managers to promote consistent operations, efficient use of resources, and sharing knowledge / best practices. Support management of CDM shared services in achieving common goals. Promote teamwork across therapeutic areas. Find common ground, communicate and proactively share information amongst therapeutic team.
• Serve on Capability teams to improve processes and to set/revise standards. Assist in activities for submission studies and audits. Mentor on and offshore personnel. Recognized as a People Developer through the Confidential Employee Global Survey

Specialist - Clinical Data Project Manager/Data Management

Confidential, Collegeville, PA

Responsibilities:

• Manage and control access to studies in Oracle Clinical. Build study sites/investigator relationships in the data
• Create Confidential t blocks and assign to investigators.
• Review protocols and eCRFs for the Oracle EDC and RAVE databases as part of meeting preparations and electronic database review.
• Ensure consistency in data handling for therapeutic areas and batch validation and refresh have been executed successfully.
• Review vendor electronic data load; monitor resolutions of data entry items from workflow problem queue. Perform project management activities, including tracking of database design and build completion. Promote teamwork across therapeutic areas by sharing information and communicating proactively. Supervise and mentor staff in routine operations of data management activities conducted both on and off-shore.

Clinical Data Coordinator

Confidential, North Wales, PA

Responsibilities:

• Responsible for the review and validation of clinical trial data.
• Develop, review and test data validation specifications and input.
• Ensure adherence to SOPs, clinical study guidelines and FDA regulations.
• Support new staff
• Responsible for writing study specific procedures and edit checks in order to maintain a flawless database.
• Perform manual audits of study documentation to ensure sponsor requirements are followed Coordinate with sponsor to ensure specific study time lines and deliverables are adhered to as required.
• Successfully work between various sponsor databases utilizing multiple data management systems including Oracle.
• Assist in testing clinical databases for new clinical studies. Query generation and resolution while working in the eCRF environment.
• Review adverse event reporting, study files and data submissions for quality assurance.

CRF Tracking and Imaging Assistant, Document Management

Confidential, North Wales, PA

Responsibilities:

• Responsible for tracking and processing all Case Report Forms (CRF) and related documentation within CRAMS an Oracle-based tracking system as well as ensuring FDA compliance.
• Interact with various overseas offices related to CRFs. Perform quality control reviews to ensure quality and completeness of documentation.
• Maintain productivity statistics as required. Act as customer interface for various requests.
• Conduct database searches as necessary to complete management and customer requests.

Operations/Event Coordinato

Confidential, Pottstown, PA

Responsibilities:

• Performed consultant activities for banquet preparation to include cost analysis in relation to clientele budgetsensuring customer satisfaction and managing overall staff event coordination.
• Responsible for overall design and implementation of floor plans for all events, complete revisions for changing priorities per clientele requests.
• Manage staff of 30 employees for outdoor events and facilities management. Interact with local and regional business associates for Public Relations in support of Corporate Products.

Investigator/Security Officer

Confidential, Myrtle Beach, SC

Responsibilities:

• Interacted with Human Resources Departments, Business and Resort Managers to assess investigation requirements.
• Conducted internal undercover surveillance to provide further grounds for employee theft investigations.
• Accompanied celebrities to various public events to administer armed personal security. Assisted local police authorities to encompass investigation activities of various suspects, provided documented evidence, and assisted in serving both arrest and civil warrants.
• Interviewed employee fraud suspects, provided documentation to further support investigation activities.
• Responsible for daily documentation and procedural reports.