Ignacio Olaso Bengoechea

▪ Supports project leadership in ensuring clinical operational delivery is in accordance with Good Clinical Practice (GCP), ICH guidelines and Health Authority regulations.

▪ Responsible for the management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out.

▪ Responsible for the successful execution of clinical elements of the assigned trials and in ensuring the completion of clinical trial deliverables.

▪ Works in close collaboration with other functional team members to ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned clinical trial(s).

▪ Supports the training and mentoring of clinical team members.

▪ Supports the Project Director/Project Manager (PD/PM) in the development of study related documents (e. g, protocol and protocol amendments, clinical plans and guidelines, including clinical monitoring plans, Informed Consent Form templates, study specific manuals, CRF completion guidelines, PSV/SIV and other training tools and training materials).

▪ Reviews site visit reports and ensures monitoring (i. e, scheduling and scope) is executed per monitoring plan.

▪ Accountable for the quality of site performance for assigned sites. Responsible for collaborating with the CRA to develop any Corrective and Preventive Action Plan (CAPA) and accountable for ensuring that the CAPA is delivered and issues escalated to the PD/PM.

▪ eTMF review and maintenance.

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Participating in 3 Phase I/II studies of hematology, oncology and ATMP (Advanced Therapy medicinal products) in Belgium, UK, Italy, France and Spain
• Participating in BDMs.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

• Ensure the correct understanding of the needs of the development plan from strategy to detailed tasks by all the people involved
• Analyze the needs of each project and design stages and milestones in calendar (scope, goals, schedule, timelines, quality, resources, etc.)
• Propose alternative or contingency solutions to changes or problems in implementation
• Propose allocation of responsibilities and resources
• Ensure optimization of resources (capital, effort, organization, departments, systems, etc.), time, cost and quality
• Establish communication and control system (system of recording and reporting on project progress, deviations, shares, etc.)
• Track each phase in order to ensure the implementation of all actions to improve and ensure a high level of quality and compliance with the set standards
• Participating in phase II and III studies of contraception and COVID-19.
• Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
• Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
• Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.

• Client Relationship management: Represent ClinTec at local and regional client meetings; dedicated local point of contact for all client operational; business performance and employee performance related matters
• Individual Line Management: Conduct employee’s meetings; oversee team member performance; provide guidance or prepare training on practical aspects of clinical trial monitoring; ICH-GCP, time management; general processes
• Resourcing and onboarding: Propose to client qualified, fit for purpose, personnel aligned to role requirements; Support new employee onboarding including induction, distribution of company equipment, explain ClinTec employee process and procedures; support new assignee onboarding including stewardship and oversight of client required training processes to assure all required trainings are undertaken, followed and completed within the required timeframe
• Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
• Team Management: Assure timely dissemination of key ClinTec and client business messages to team members; Organise team building sessions, group meetings, trainings and other events as necessary to promote a positive working culture and promote employee motivation
• Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
• Assisted senior leadership in managing all aspects of operations.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Led teams of up to 15 personnel, supervising daily performance as well as training and improvement plans.
• Miscellaneous: Support ClinTec global communication strategy by providing regular reports and updates to management and participation in management meetings as required; Complete required ClinTec and client systems and process trainings and assure understanding of all relevant key processes for self and team; other tasks where required or instructed by management

• Same responsibilities described above (Clintec)

• Maintains timely and effective communication among team members and site staff
• Assures compliance with local regulations, ICH and GCP guidelines, and Company and Sponsor SOPs
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Responsible for site management and site staff; performs source data verification according to contractual requirements
• Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan
• Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions
• Maintains awareness of key study performance indicators for own sites
• Documents and tracks the resolution of all outstanding site specific protocol-related issues from visit to visit
• Prepares for and attends Investigator meetings
• Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans
• Local LCRA in paediatric study.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.

• Similar responsibilities as SCRA in INC Research. See above.

▪ Similar responsibilities as SCRA in INC Research. See above