Supervises all the operational trial related activities and the operations team assigned to the trial. Accountable for ensuring the delivery of global operational outputs in accordance with the trial timelines and quality standards. Responsibilities include:o Represents the Clinical Development Operations at the Project Level for a specific compound, and handle preliminary activities as required, providing operational input to the project planning.o Handles cross functional project assignments and/or cross functional leadership activities.o Leads a cross functional team with focus on the operational activities.o Presents to Senior Management for approval of operational trial deliverables challenges, budget and innovative ideas overcoming challenges.o Leads the implementation of the operational strategy to ensure operational trial deliverables are provided on time and within budget.o Monitors the trial budget for operational costs.o Chairs functional or cross-functional meetingso Oversee the resource forecast for cross-functional and regional teams.o Accountable for ensuring an adequate site selection, collaborating with other functions.o Develops high level country plans and site strategy plans in collaboration with program and trial teams.o Accountable for oversight of operational committees and vendors, including availability of key documents and adherence to key timelines. Accountable for the timelines of HA and EC/IRB submissions together with the cross-functional teams.o Accountable for ensuring CAPAs for site/trial level and vendor audit reports are adequate.o Accountable to deliver and monitor a site quality plan for the trial together with the cross functional team members.o Act as Sr. COM as required.

Supervises all the operational trial related activities and the operations team assigned to the trial. Accountable for ensuring the delivery of global operational outputs in accordance with the trial timelines and quality standards. Key responsibilities include:o Provide operational input to the project planning, trial plans and activities affecting the operational performance and quality of the trial.o Lead operational planning and trial related activities in close collaboration with other functions.o Supervises the operations team assigned to the trial and provides clear instructions and sets priorities.o Support in selection and management of ESPs and CROs and the development of trial related operational documents.o Manages clinical trial supplies in close collaboration with Technical Operations (forecasting, ordering, distribution, import/export licenses).o Conduct trial specific training to assigned operations team and CROs/ESPs.o Supervise the Study Master File to ensure completeness and audit readiness. Perform ongoing quality checks/review.o Participate in Investigator meeting preparation and presentations, Site Selection Visits and Site Initiation Visits.o Support business unit/departments in internal audit preparations and during audits. Ensure the follow up and resolution of audit findings related to operational activities.o Line Management of Clinical Operation Coordinators and/or Clinical Operations Managers when applicable: lead, mentor and coach direct reports.

Perform trial management activities/responsibilities for multiple phase clinical studies on a global level. Work closely with cross-functional groups to ensure successful completion of the study. Responsibilities include:o Manage trial activities and ensure delivery of global operational output in accordance with SOPs, ICH/GCP guidelines, timelines and budgeto Chair project management team meetingso Ensure adequate trial-specific training of assigned team memberso Participate in the selection and management of external service providerso Review vendor invoices to ensure work is performed and in accordance to the scope of worko Create the global investigator budget and payment schedules as appropriateo Contributes to preparation and/or review of all trial related documentso Forecast global supply needs, orders supplies and ensures timely distribution globally (e.g. IMP and other materials)o Organizes and supervises preparatory activities for Investigator Meetings as well as participate and present during the meeting.o Perform ongoing quality check/review of the study master file and ensure completeness and audit-readiness.

Perform project management responsibilities for multiple phase III/IV global clinical studies in North and South America. Responsibilities include: o Site selection, training and management of external service providers o prepare and/or review all trial-related documents for study drug release o contribute to development and update trial-related risk management and contingency plans and identify new risks o ensure adequate distribution of specific procedures and supplies to team o support feasibility activities o support submissions to Health Authorities for US, Canada and Latin America as needed o prepare investigator meeting material, participate in presentations and contribute to monitor training o forecast study supply/IMP supply for country/region (US/Canada/Latin America) o Provide input on global investigator budget/financial plan, including guidelines for responsible regions o Oversee trial progress, assist in resolving issues on country/regional level, identify deficiencies and implement corrective action plans

Managed up to 6 studies at one time.Assisted in writing guidelines, creating forms, creating mock CRFs, managed budgets (site/vendor), approved invoices, reviewed investigator payments, managed collection of data (CRF pages/queries).Reviewed regulatory documents, ensured essential documents available in order to ship study drug to sites. Assisted with preparations for two FDA audits.Assisted in providing information for Final Study Reports for various studies.

Reviewed data for various studies in IPF, PAH and Scleroderma.Collected CRF pages, queries, reviewed regulatory documents.Followed ICH/GCP guidelines to ensure compliance at sites.

Assists team members whenever necessary to facilitate a successful completion of the clinical program. o Perform on-site monitoring o Primary communication link between site and sponsor o Ensure site files are up to date o Perform source document verification, review original CRF, ensure accuracy of query responses o Ensures investigative site is in compliance with protocol, guidelines and regulatory requirements

Assist with development of clinical program. o Review and coordinate study related documents for filing o Assure protocol specific procedures are being followed correctly o Train new clinical assistants on study o Coordinate drug re-supply shipments o Track data and supplies o Provide weekly study specific updates o Take minutes for meetings and distribute to team

Serve as liaison with CRAs, investigative sites, client personnel. Negotiate, review and transmit regulatory documents, study agreements and grants. Assist in interview and evaluation process.

Provide daily administrative and clerical support to project teams. Maintain regulatory files for various projects.

Maintain regulatory documents according to company SOPs. Prepare site file binders for various studies and distribute to sites. Archive files for completed studies. Provide training to new hires on department processes and procedures.