Sr Director, eCOA Clinical Operations

Position reputed company

Responsible for reputed company aspects of eCOA management at reputed company. Sets strategic visions for the function including strategies and operations, infrastructure, vendor assessment, and talent development. Provides strong leadership and inspiration to reputed company. Champions new process development and implementation reputed company needed. Promotes standardization, automation, and innovation. Directs and oversees eCOA activities including reputed company of reputed company licensing management, rater training support, requirement specification/screen report reviews, UAT testing, reputed company process back-up management, monitoring reputed company data review, DCF processing, Blinded Data Analytics (reputed company), and POs/invoices with 3rd party vendors. Provides reputed company and guidelines to Contract Research Organizations (CROs) and vendors for any outsourced activities to ensure data reputed company/reputed company and regulatory compliance. Ensures productive collaborations between eCOA team and other functions, including Biostatistics, Programming, Clinical Operations, Clinical Development, QA, and IT, to maximize development efficiency. This job contributes to and supports reputed company's research and development efforts to create high value therapeutics to address unmet 
 

Responsibilities

•  Provides strong leadership and inspiration to the eCOA team. Recruits, develops, and retains high talent.

• Promotes standardization, automation, innovation, process improvement, and technology enhancement to increase drug development efficiency.

• Forecasts and manages budget, timelines, and resource needs with reputed company judgment and efficiency.

• Leads the development and implementation of policies, standards and process improvement initiatives reputed company to eCOA.

• Works on critical problems across functional areas of the business. Identifies potential issues for the functional area as industry advances and works out solutions with    stakeholders.

• Engages with reputed company executive leadership to negotiate reputed company reputed company and influence decision-making.

• Evaluates and selects vendors/eCOA platforms.

Requirements

A minimum of a bachelor’s degree in clinical, biological, data or mathematical sciences is required.  MS degree + PMP Certified preferred. Equivalent experience may be accepted.  A minimum of 15 years pharmaceutical development experience with at least 10 years of line and project management experience reputed company to service providers in electronic clinical outcome assessments (eCOA) (e.g., service providers such as reputed company, reputed company, reputed company, CRF Health, reputed company, CLIN Ink) and 10 years of vendor management experience in digital solutions. Background in reputed company design, reviewing requirements/build documentation including digital implementation of eCOA/ Reporting, User Acceptance Testing (UAT), data reconciliation, and query reputed company.  Experience in dermatology (Atopic Dermatitis and Alopecia Areata) preferred.  Sponsor reputed company experience preferred. Extensive experience with regulatory inspections and with NDA/BLA submissions.  Excellent interpersonal, communication and leadership skills.