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.

-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.

• 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.
• Report data trends to management and provide status updates to applicable teams.
• Assist with training of data collection and management requirements for assigned trials.

• 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.
• 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.

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

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