Mark Romano Email & Phone Number

Upper Darby, Pa, Us

Lawrence Township, Nj, Us

Led global IT operations for Veeva Vault Regulatory and Vault Safety platforms. • Directed cross-functional teams to ensure operational excellence and efficiency.• Served as the primary IT operations lead to business partners and technology vendors.

Lawrence Township, Nj, Us

Led IT activities for Veeva Vault Regulatory and Vault Safety at BMS, collaborating with matrix teams and vendors.• Managed in-house vendor support teams and outsourced operations analysts for project execution.• Ensured smooth execution of support activities, project deliverables, and system releases.

Limerick, Ie

• Aligned with customers to develop success plans, measure KPIs, and identify ongoing improvements. Educated customers on new product features, collected feedback, and guided best practices for product consumption.• Acted as the primary customer liaison, managing communications between project team, customer, and internal stakeholders.

Pleasanton, Ca, Us

• Managed customer success for up to 30 enterprise and mid-sized customers, promoting strategic focus and program management.• Developed and delivered presentations to support updates to Veeva’s Vault applications.• Guided customers on best practices for change control and validation surrounding Veeva Vault releases.

Blue Bell, Pa, Us

• Managed team collaboration by overseeing direct reports and advocating to senior management.• Participated in director-level meetings within the Clinical Operations department.• Conducted interviews for various departmental positions.

Blue Bell, Pa, Us

• Managed operational, financial, and contracted services for various clinical trials, ensuring compliance and timely completion.• Developed protocols, CRFs, regulatory documents, and study master files to support study conduct and deliverables.• Oversaw project progress, recruited investigators, and supervised monitors to ensure study timelines were met.

• Led a Phase III double-blind Multiple Sclerosis trial and a pediatric vaccine trial, overseeing vendors and managing issues.• Collaborated with cross-functional teams to ensure trial success and adherence to regulatory requirements.

Paris, France, Fr

• Managed operational and financial aspects of approximately 25 Phase I studies from study start through clinical study report.• Developed and managed clinical trial budgets, vendor relationships, and study-specific procedures.

New York, New York, Us

• Provided functional oversight and training to operational staff on Transplant studies, ensuring program objectives and milestones were met.• Collaborated with cross-departmental teams to develop best practices for strategy implementation and risk management.

New York, New York, Us

• Managed global Phase IV clinical research studies on cardiac and renal transplant recipients, overseeing operational and financial aspects.• Led matrix study teams of medical monitors, clinical scientists, local affiliates, and vendors to ensure successful trial execution. Collaborated with cross-functional departments to ensure proper study conduct.

Dublin, Ie

• Trained new Quality Assurance personnel, mentored two junior auditors, and assisted in developing departmental SOPs and report templates.• Selected as Quality Assurance liaison to a newly acquired company by ICON Quality Assurance management.

Dublin, Ie

- Conducted and led sponsor, regulatory, ISO registration audits, and investigator site audits; provided GCP and ICH training to staff; performed external contract audits and reviewed critical regulatory documents.- Supported and evaluated multiple clinical trials across various therapeutic areas; audited contracted departments and deliverables, generating formal documentation for all activities.

Dublin, Ie

Performed all study visits (Pre-Study, Initiation, Monitoring, and Closeout) and related activities for assigned sites.

Dublin, Ie

Performed in-house trial activities for multiple studies.