Robin Barber, Pmp Email & Phone Number

Spring Hope, Nc, Us

United States

Raleigh-Durham, North Carolina Area

Raleigh-Durham, North Carolina Area

PRIMARY RESPONSIBILITIES• Identifies project guidelines and communication needs by• Establishing clear and measurable project operating guidelines with Account Executive and Sponsor representatives• Defining timelines, milestones and limitations for project staff• Establishing project reporting schedules with Account Executive and Sponsor representative• Providing project updates to Sponsor representative(s) and Account Executive on schedule• Communicating timely, appropriate project information to project teams, sponsor, sponsor vendors and sites• Performs project analysis and management• Provides project team leadership • Maintains Quality Service and Departmental Standards

Morrisville, North Carolina

• Overall responsibility for management and direction of the study project team and all aspects of clinical project management, including timelines, budget and deliverables as assigned.• Client satisfaction, as measured by the extent to which the project meets objectively defined goals and by the subjective project evaluation of the influential persons within the client organization.• Participation on cross function Implantation Team during new product implementations and roll out of new version of existing products• Contribute to product and SOP development.• Lead process review and documentation• Review roll out plans by IT, marketing and R&D for their effect on operations• Review of Product Training Plan produced for implementation• Participate in sales presentations.• Leading the project team while taking an active part in the client team.• Project and budget planning.• Communicating client requirements to the project team.• Interact with internal team from various departments to ensure quality of service.• Performing all activities in accordance with applicable law, regulations and SOPs.• Assist line management in ensuring that all procedures are executed in accordance with applicable laws, regulations, and SOPs.• Mentor employees to follow a disciplined method for building positive relationships with clients, and for developing procedures and technology that meet client needs.• Provide project-specific and/or product training to users.• Other responsibilities may be assigned.

Morrisville, Nc

• Responsible for all client communications, conflict resolution, and compliance on client deliverables.• Reviews all major deliverables to ensure quality standards and client expectations are met. • Ensures that client issues are dealt with in an efficient manner, informing the SMT of any problems that may arise or need escalation. • Owns the contract review process (includes the generation of project specific assumptions). • Generates and/or reviews Change Orders and assists in payment collections/signatures. • Directs all project teams in order to maintain a continuous knowledge of project status in order to identify potential issues and/or opportunities within or related to the project. • Directs resources assigned to the account and provides input to performance reviews.• Manages multiple direct reports including Project Managers, Application Developers, and Study QA analysts (as the account grows, additional PM’s will report to the AM).• Ensures that all processes and procedures are completed, quality standards are met, and that projects are profitable. • Aware and in pursuit of opportunities for account growth and new business, involving the VP of Sales or assigned BD rep.• New therapeutic areas• New Merge technologies• Communicates the client's goals and represent the client's interests to the team. • Provides regular two-way communication between the client and team, to provide strong team representation and set proper client expectations. • Understanding of company capabilities and service, and effectively communicates all offerings to the client. • Provides regular input on all account activity on a weekly basis.

Morrisville, Nc

• Overall responsibility for management and direction of the project team and all aspects of clinical project management, including timelines, budget and deliverables.• Client satisfaction, as measured by the extent to which the project meets objectively defined goals and by the subjective project evaluation of the influential persons within the client organization.• Communicating and obtaining approval for resource requirements with etrials management.• Participate in sales presentations• Leading the etrials project team• Managing client interactions and expectations.• Project planning and Primary liaison between clients and etrials.• All project documentation and reporting to include the development of project specifications.• Communicating client requirements to the etrials project team.• Interact with internal team from various departments to ensure quality of service.• Regularly reviewing the ongoing work of the etrials project team to ensure consistency with client requirements, client expectations, project budget and timelines.• Performing all activities in accordance with applicable law, regulations and etrials SOPs.• Assist line management in ensuring that all procedures are executed in accordance with applicable laws, regulations, and etrials SOPs.• Contribute to product and SOP development in other etrials departments.• Mentor employees to follow a disciplined method for building positive relationships with clients, and for developing procedures and technology that meet client needs.• Ensure delivery of validated database to sponsor.• Provide project-specific training to software users.• Plan and present material at investigator meetings.• Understanding of the clinical trial process and the use of electronic systems within this process.• Participated in the Clinical Express team to improve processes/procedures.• Experienced in Microsoft Office Applications.• Other responsibilities may be assigned

Morrisville, Nc

• Responsible for overall site management, in conjunction with project assistants, of projects to which he/she is assigned, including but not limited to, providing username/password access and privileges for study participants to assigned studies.• Responsible for second line client contact as related to Help Desk calls as well as escalating calls as needed to IT and/or the assigned Project Manager.• Responsible for development and distribution of help and user manuals in conjunction with the assigned Project Manager.• Assist and/or conduct training sessions with Sponsor-designated personnel, as needed.• Responsible for supporting an assigned study or studies in conjunction with the Project Manager to include the management of multi-trial/multi-site studies, as applicable.• Assist with training new staff as well as participate in project management discussion groups, project planning meetings, in-services, etc., in preparation for a Project Manager role.• May be assigned specific studies and, as directed by the Project Manager, will be responsible for independently managing aspects of those studies to include start-up, maintenance and close-out of given studies.• Contribute to product and SOP development in Operations and other etrials departments.• Mentor project assistants to follow a disciplined method for building positive relationships with clients and developing procedures that meet client needs.• Project Manager and other duties may be assigned as needed

Raleigh-Durham, North Carolina Area

• Mentored and motivated data management staff.• Developed and implemented study-specific Clinical Data Management Plans which met sponsor specifications. • Functioned as a study Lead Data Manager or co-lead on clinical data management programs.• Provided project specific training and updated study team training records.• Developed database specifications (e.g., annotates Case Report Forms) and specifications for external data sources.• Wrote user test plans for data entry screen, electronic edit checks and medical coding.• Performed user testing and analysis of electronic edit checks and medical coding.• Wrote functional specification for electronic edit checks, quality control listings and non-standard clinical study data reports.• Ensured that all clinical study data captured and maintained by external vendors was incorporated into the study database in collaboration with Clinical Programming. Identified and corrected discrepancies between the clinical database and data merged into the database from external sources.• Performed medical data encoding as specified in study-specific coding plans and the study protocol.• Ran, reviewed and distributed reports to internal study team and sponsors.• Created data management timelines with project team based on productivity standards and sponsor expectations.• Tracked data processing progress and communicated problems/backlogs to project team and management.• Maintained an awareness of the project scope of work and notified senior management of all sponsor requests that were outside current scope in accordance with relevant SOPs/WIs.• Calculated and monitored productivity on studies.• Participated and led in the implementation of new technologies and services.• Presented data management processes during pre-award meetings with potential sponsors.• Attended Investigator meetings and presented data management functions

Cary, Nc

• Assisted in planning, construction, testing and maintenance of clinical database management systems (Oracle Clinical).• Assisted in data validation, lab data load and data transfer according to client specifications.• Documented clinical trials databases.• Participated in project teams.• Set-up data entry screens.• Medical coding.

Cary, Nc

• Designed Data Management Plan, Validation Manual, Data Handling Guidelines and other key study documents.• Compiled study documents for Data Management Master File.• Validated database creation and implementation.• Validated processing specifications to guarantee programmed checks work accurately throughout a study life cycle.• Supervised and performed study specific edit checks and cross CRF validation processes.• Assisted in the creation of Case Report Forms (CRFs) in coordination with protocols.• Successfully managed and supervised database audits while complying with contractual Quality Control Plans.• Oversaw and performed reconciliation of SAEs and all external study vendor data.• Managed direct internal and external resources for deliverables.• Assisted with the approval of Annotated CRFs (Oracle and SAS).• Created Data Management task specific timelines and supervised Data Management activities to ensure contractual obligations were achieved. • Oracle Clinical Trainer of new staff without Oracle experience.• Oracle v4.5 Validation Team.• Oversaw scanning of CRFs.• Medical Coding (MedDRA versions 5.0-8.0 and WHODD 2003Q1-2005Q1). • Performed discrepancy management activities including, but not limited to query generation and resolution.• Monitored status of study materials including, but not limited to, DCFs and CRFs.• Responded to data entry personnel questions on readability/enterability of data.• Responded to data coordination issues raised by assigned CDCs.• Placed datasets on a secure server.• Ultraeditor experience: locating and slightly modifying SAS programs.• SAS V6.12 experience. • Preformed Data Transfers to sponsors via a secure server.

Cary, Nc

• Acting Data Manager 12/2002 to 6/2004.• Assisted Clinical Data Manager in creating, reviewing and processing Data Clarification Forms and updating databases.• Reconciled first and second pass data entry. • Visually reviewed data listings to CRF.• Assisted in the set-up of patient and investigator information and the login of CRFs.• Assisted Clinical Data Manager in other miscellaneous activities as required.• Medical Coding (MedDRA versions 5.0-7.0 and WHODD 2003Q1-2004Q1).• Performed discrepancy management activities including, but not limited to, query generation and resolution.• Monitored status of study materials including, but not limited to, DCFs and CRFs.• Responded to data entry personnel questions on readability/enterability of data.• Responded to data coordination issues raised by assisting and assigned CDCs.

Pmp Certification 27Jul2013, Pmp Prep Boot Camp

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Project Management Fundamentals

Planning, Executing And Controlling (Project Management Principles Ii)

Introduction And Overview Of Project Management (Project Management Principles I)

Medical Assistaning

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