Ginger Dalton Email & Phone Number

North Chicago, Illinois, Us

North Chicago, Illinois, Us

Leopardstown, Dublin, Ie

Morrisville, Nc, Us

-Produce site specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review-Negotiates budget and contract with site -Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level-Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions-Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings-Collaborate with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues-Facilitates the execution of contracts by company signatories

-Initiate and facilitate BCRA approval process for, but not limited to, Confidential Disclosure Agreements, Master Service Agreements and Project Specific Agreements. Liaise with Mylan Legal in facilitating progress of key departmental contracts through LCM to ensure timely execution. Receive and respond to BCRA inquiries throughout the BCRA approval process and responds in a timely manner.-Tracks and reports developments on a regular basis towards contract completion.-Liaise with departmental personnel and 3rd party vendors to ensure Mylan obligations associated with Federal Sunshine Act reporting are adhered to for all departmental contracts involving US Health Care Professionals.-Distributes and coordinates external vendor request forms to ensure appropriate tax information is collected. -Process and track departmental invoices payment and reconcile monthly statements with vendors to ensure on time payment. Assist with establishing monthly budgetary spend and forecasting as requested.-Integrate strategic sourcing activity within the portfolio of managed categories through effective change management and communication utilizing Global Category Management principles and techniques.-Provide Clinical Category support to team members, and champion the utilization of the Mylan strategic souring process to develop and implement sourcing strategies for the portfolio of managed categories, ensuring review and approval by key stakeholders and Procurement leadership.Support and lead negotiations for specific studies for clinical identified by group leadership.-Promote the establishment of cooperative relationships with key suppliers and ensures that all suppliers are treated in a professional, ethical and fair manner. Measure supplier performance using rating systems or predetermined standards including Key Performance Indicators (KPIs) and Service-Level Agreements (SLA)

•Provide quality control review of study documents for accuracy and completeness to ensure study integrity and data quality. Work with Clinical Research Associates to ensure clean and accurate reporting of data. •Develop, implement and evaluate clinical data management processes and standards for clinical operations. •Responsible for the coordination and communication of internal or CRO data management activities. •Assist in ensuring data collection processes are aligned with current applicable standards with respect to CDISC, especially CDASH standards. Assist in ensuring that eCRFs, eCRF completion guidelines, and data validation specifications are completed prior to implementation of EDC study-specific applications. Enforce compliance of clinical studies with Good Clinical Practice (GCP), Federal regulatory guidelines, requirements and internal procedures. •Report data trends to management and provide status updates to applicable teams. •Assist with training of data collection and management requirements for assigned trials. •Contribute to metric and performance measure tracking. Participate in the preparation and presentation of data when applicable. •Assist with close-out of study files and legal document collections. •Responsible for archiving clinical study documents and maintenance of inventory. Assist management in determining retention requirements for clinical files and drug products based on submission/approval timelines.

• Assist in the coordination and communication of internal or CRO data management activities• Assist in evaluating and selecting CRO vendors.• Assist in preparing for and ensuring that database lock is achieved according to project timelines and criteria specified in the Data Management Plan.• Assist in reporting trends to Clinical Operations colleagues and management; escalate potentially troublesome trends to management; work with statisticians to understand their analysis requirements and their data quality requirements.• Assist in the writing and review of the Data Management Plan and Database Lock Plan.• Assist with study-specific application setup, verification, modification, deployment, cleaning, and lock: assist in developing trial data specifications, including electronic case report form (eCRF) creation and workflow, eCRF completion guidelines, and edit check rules.• Assist in ensuring internal data collection processes are aligned with current applicable standards with respect to CDISC, especially CDASH standards.• Assist in review of Standard Operating Procedures (SOPs) as needed.• Assist in ensuring that eCRFs, eCRF completion guidelines, and data validation specifications are completed prior to implementation of EDC study-specific applications.

Blue Bell, Pa, Us

Blue Bell, Pa, Us

• Performs validation and verification (test script writing/test script execution) of software systems for assigned projects• Performs validation and verification (test script writing/test script execution) of software modification for assigned projects• Creates test result documents for review• Reviews and signs off on software testing to ensure that the testing requirements have been met when performed by another IT QA Analyst• Aids in the update or development of various required documentations to meet industry standards and UBC Standard Operating Procedures• Assumes responsibility for creating and updating assigned database user manuals for UBC personnel and their clients• Conducts staff training on new software systems and software modifications for assigned projects• Performs validation and verification (test script writing/test script execution) related to edits for assigned projects• Performs related duties as assigned by the IT QA Manager

Blue Bell, Pa, Us

• Ensures all departmental/project tasks are completed• Conducts departmental/project team meetings to ensure associates are informed of changing policies and procedures, as directed by manager• Responsible for training of new employees• Provides new and/or updated training materials as needed• May participate in the interview and evaluation process within their respective department• Handle inbound and outbound contacts from various sources (patients, healthcare providers, etc.) related to a specific UBC program• Provide consistent customer service support to all stakeholders for the assigned program• Working knowledge of program guidelines, medication, or disease being referenced in call scripts• Conduct communication through various channels (phone, fax, email) to retrieve data or to address discrepancies in data received• Apply corrections and/or updates to the secured program applications and/or CTMS and appropriate documents, that have been identified through data verification or follow up calls• Escalate potential problems or issues that require management’s immediate attention and provide a summary with appropriate detail to his/her direct report• Document all communications in the appropriate application contact log in an accurate, concise and timely manner as defined in the Standard Operating Procedures• When applicable, may assist in the process to recruit or initiate sites and coordinate launch activities• When applicable, may be responsible for preparation and shipping of program materials and documenting action within the appropriate application and/or CTMS• Ensure data entry, filing, and data confirmation are completed accurately and in a timely manner• Answer in-coming calls from various sources (patients, healthcare providers) related to a specific UBC study• May provide consistent and thorough screening of patients to provide a more qualified patient to each site