Juliane Ebert Email & Phone Number

I lead, execute, and achieve site activation and amendment deliverables globally and/ or within a region for assigned projects, managing the scope of work to meet timelines, costs, and quality standards. I ensure all project deliverables meet contracted and customer expectations by providing accurate projections, reports, updates, and ongoing risk assessments. I develop and maintain strategic relationships with customers in alignment with assigned projects, ensuring that individual project targets are met and services are provided to the highest quality standards. I serve as the primary Start-Up contact for the project lead and client. In my projects I have weekly calls updating the sponsor on study status and addressing current project needs. Additionally I focus on the study strategy as well as the financial coverage of the study during its start up period. Part of my job as an STM is to make sure that all different roles are aligned and work together to allow a timely site activation, including but not limited to regulatory, contract management, vendors and the clinical team. I have experience in Start up in APAC, EMEA, JPN, LATAM and NA.Bid defence participation: During bid defences I am responbsible for presenting the study start up strategy, risks and mitigations in the proposed study with respect to the country mix and patient population. During this I am working closely with the other functional members of the team.

Deutschland

Deutschland

SCRAII-SIA: As a Clinical Research Associate in Site Intelligence and Activation, I perform and coordinate the identification and selection of qualified study sites, conducting site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. I work in conjunction with the Country Approval Specialist and Contract Specialist(s) to prepare investigational sites for initiation. I represent PPD in the global medical research community and develop collaborative relationships with investigational sites.

CAS: prepares, reviews and coordinates local regulatory submissions (MOH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. Coordinates with internal functional departments, to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines. Ensures the submission process for sites and studies are aligned to the critical path for site activation. Has contact with investigators for submission related activities and serves as a key contact at country level for either ethical or regulatory submission related activities. Achieves PPD target cycle times for site. Prepares regulatory compliance review packages, including working with the SIA CRA as applicable. Develops country and site-specific patient information sheet/informed consent form documents.Performed document and submission activities for 2 oncology studies.As a member of the Protocol Review Team, I was responsible for answering questions from study teams and bid defense teams regarding country-specific regulations and practices for Germany, Austria, and Switzerland. I reviewed protocols to provide recommendations and assess the feasibility of conducting studies in these countries. Part of this was to review available marketed drugs for certain indications and identified potential risks and mitigation strategies. Another aspect of this task was also reviewing challenging queries from different studies and the proposal of answering strategies.Subject Matter Expert (SME) for Ethics Committee (EC) and Regulatory Agency (RA) Submission Processes in Switzerland: As the SME for EC and RA processes and submissions, I served as the primary point of contact for country team members and study teams regarding all questions in these areas. My responsibilities also included maintaining the company database for Switzerland, ensuring it was up-to-date for both EC and RA processes.

Deutschland

Site Identification and selection

Monitoring ( including site activation and close out)performs and coordinates identification and selection of qualified study sites, site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. Works in conjunction with the Country Approval Specialist and Contract Specialist(s) to prepare investigational sites for initiation. Represents PPD in the global medical research community and develops collaborative relationships with investigational sites. Performed the site identification and selection process as well as assisted with the submission activities for 2 dermatology studies, 1 endocrinology study.

Master Of Science - Ms, Molecular Biotechnology, 1.1

Bachelor Of Science - Bs, Molecular Biotechnology, 1.7