•Lead the development of overall strategic planning for assigned clinical trials including timelines, budgets, CRO/vendor oversight plans, key deliverables, and risk/mitigation strategy.•Assessing the operational feasibility and recommendations on the study execution plan; assist in developing and managing comprehensive clinical study timelines, metrics, budgets; provides study-specific training and leadership to clinical research staff.•Prepare and present project debriefings as required.•Plan, execute and lead study-specific meetings.•Monitor the overall CRO/vendor performance and study health as it relates to timelines, budgets, and quality, and ensure all clinical study deliverables are met in accordance with the timeline, budget, and resource requirements as well as in compliance with relevant regulations and guidelines.•Responsible for ensuring that CRO and Clinical Project Team delivers timely and satisfactory Project deliverables with high quality.•Review list of approved sites for selection visits•Work with the study team to design clinical protocol; provide input for the design of the ICF template, source documents and CRFs.•Coordination of intellectual property and clinical study supplies and oversee overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS•Lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigators Sites, vendors, etc.).•Lead and partake in regular team meeting / teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Investigator Meetings as necessary.

Global Clinical Trial Manager of two Phase I CAR-T studies.

•Managing a Phase I Global Immuno-oncology study•Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, assumes Lead CTM responsibilities on regional level, Clinical Study Manager responsibilities and takes on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.•Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan for providing clinical related documents. Participates in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.•Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the timely archiving of documents and study materials for the department.•Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions and managing CRF collection and query resolution. •Coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. •Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

• Supports the planning and execution of one or more Phase 1 – 4 clinical research studies. • Performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget and in support of company objectives. • Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and client policies and procedures).• Supports the Study Project Manager in leading the cross functional study team:-Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)-Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date• Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)• Supports the vendor selection, scope development, management and oversight of external vendors in compliance with Client’s processes and procedures and the applicable regulations.• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies• Proactively identify and resolve and/or escalate study related issues

*Main Regulatory Contact for 94 clinical trials.*Provide main administrative support for the preparation of multiple Institutional Review Board (IRB) documents.*Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, SAEs,continuing progress reports, and consent-to-treat documents.*Following IRB guidelines, draft and/or modify documents as required by research program activities.*Support faculty with Investigator-Initiated IND/IDE applications; maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required.*Facilitate study start up activities, as necessary, including: submissions to Scientific Review Committee (SRC),*Data Safety Monitoring Board (DSMS), Institutional Biosafety/Radiation Safety Committee, andClinicalTrials.gov postings.*ISF maintenance.

•General monitoring and site management responsibilities for a Phase III Prostate Cancer trial.•Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.•Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.•Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study pro-cedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.•Trains site staff on the EDC system and verifies site computer system.•Conducts periodic site file audits to ensure compliance with GCPs and Sponsor standard operating procedures.•Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.•Performs validation of source documentation as required by sponsor.•Prepares monitoring reports and letters in a timely manner using approved CRO/Sponsor forms and reports.•Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.•Ensures return of unused materials to designated location or verifies destruction as required.•Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.