Leading and managing multiple projects simultaneously, ensuring timely delivery and adherence to budget.Developing detailed project plans, including scope, objectives, timelines, and resource allocation.Monitoring project progress and performance, identifying and mitigating risks.Client Engagement:Building and maintaining strong relationships with clients, understanding their needs and providing tailored solutions.Acting as the primary point of contact for clients, ensuring clear and effective communication throughout the project lifecycle.Facilitating client meetings, presentations, and status updates.Strategic Consulting:Providing expert advice and strategic guidance to clients on project management best practices.Conducting thorough assessments of client needs and develop customized project strategies.Identifying opportunities for process improvement and recommend innovative solutions.Stakeholder Management:Engaging with key stakeholders to ensure alignment and support for project objectives.Communicating project status, milestones, and deliverables to stakeholders in a clear and concise manner.Managing stakeholder expectations and resolve any conflicts that may arise.Designing, planning, and executing training programs for clients and internal teams.Organizing and managing events such as workshops, seminars, and conferences to support project goals and client engagement.Coordinating logistics, including venue selection, scheduling, materials preparation, and attendee management.Evaluating the effectiveness of training programs and events, gathering feedback for continuous improvement.Collaborating with subject matter experts to develop relevant and impactful training content.Ensuring compliance with all relevant regulations and industry standards in training and event management.

Working on a wide range of clinical research related projects:• Phase III clinical trial, interventional Covid19 vaccine study in UAE, in collaboration with Gamaleya research institute of epidemiology and microbiology & RDIF (Russia) • Phase III clinical trial, Covid19 vaccine study in UAE in kidney patients (dialysis, renal transplant, CKD) • Phase I/II clinical trial, interventional Covid19 vaccine study in UAE, Combination of Oxford/AstraZeneca & SPUTNIK vaccines• Developing & setting up training program for junior CRA’s• Collaborating with a highly professional research team on setting up a Clinical Trial Unit • Providing Good clinical practice (GCP) trainings

• Being responsible for efficient project planning, execution and delivery• Managing project cost and ensure efficient utilization of resources• Understanding client requirements and regularly communicate with the client to manage expectations• Providing periodic project updates on productivity and quality to the client• Responsible for client retention and ensure increased customer satisfaction

As junior project manager I was being responsible for project administration and support. Under the direction of the project director, I was leading a global team of CRA’s and CTA’s overseeing the completion of project tasks and monitor adherence to perpetual project management process standards.Clinical Team Manager (CTM) is responsible for operational project management and acts as the direct project line manager to the allocated study Monitors. The monitors are each responsible for their sites following ICH-GCP and local regulations and health authorities when it comes to quality of data, safety reporting and regulatory. CTM oversees the site activities and proactively identifies, resolves / mitigates and escalates risks and/or issues to the PM/PD/HCO manager as necessary.

CRA main responsibilities contain management of designated clinical trials and observational studies, including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome. Organizing investigator’s start-up meeting and study site initiation meetings. Monitoring the assigned clinical trial following company SOPs and in accordance with GCP. Managing patient recruitment strategies to increase patient randomization into the trial, reviewing all (S)AE’s compliant with company procedures to ensure the participants safety.As senior CRA mainly being responsible for supervising and guiding a group of 5 CRA’s belonging to the clinical operations team. Acting as the first contact person for the team and being a link between the CRA team and the clinical project manager. This includes mentoring and overseeing the quality of employee performance, developing a timelines for the project and delegating the individual components to members of the team, performing co-monitor visits, reviewing and approving visit reports and contracts and supervising ethics committee submissions etc. IMP manager delegate: Coordinating the importation and distribution of IMP manufactured outside the UAE to the clinical sites in accordance with the company and country’s regulations. For this purpose I have followed a proper IP management training in France in 2014.

The goal of this position is the implementation, optimal organization and supervision, training site staff and coordinating clinical studies in study centers (e.g. hospitals) in the Netherlands or abroad. Working “in the field”, mainly travelling to different hospitals all over the country to visit specialists, ER physicians, nurses, laboratory and other involved study staff. CAPiTA Clinical Trial: CAPiTA stands for “Community Acquired Pneumonia Immunization Trial in Adults”. Phase 3b, Interventional, Parallel-group, randomized, placebo-controlled, double-blind trial in which subjects aged 65 years and older were randomly assigned to receive a single dose of either Prevenar 13 or placebo. A total of 84,496 subjects were enrolled. The trial was conducted by Julius Clinical, an academic research organization affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands. Fifty-nine sentinel hospitals were used for the surveillance of CAP and IPD 1 Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine. Non-bacteremic / non-invasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia. (1)1 Bonten MJM, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015; 372:1114-1125.

ALECARDIO Clinical Trial: A Phase III, interventional, international, multicenter, safety and efficacy study to evaluate the potential of Aleglitazar to reduce cardiovascular risk in coronary heart disease (CHD) patients with a recent acute coronary syndrome (ACS) event and Type 2 Diabetes Mellitus (T2D). Double-blind, parallel, two-arm study to evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of Aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Randomized patients receiving either Aleglitazar or placebo once daily as oral doses until at least 950 events occur.

Monitoring the quality of data obtained by the staff members of the (Phase 1) Clinical Pharmacology Unit in accordance with study protocol, Standard Operating Procedures (SOPs), International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and applicable regulatory requirements. Furthermore co-writing SOP’s, working instructions, study procedures and study protocols, preparing and performing study submission and study close out.