Site Start Up EUCTR I at Parexel

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

05 Jul, 26

Salary

0.0

Posted On

06 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical trial management, Regulatory affairs, EUCTR, CTIS database, Clinical trial application, IVDR, Project management, Data driven planning, Vendor management, ICH/GCP, CTMS, TMF, Microsoft Project, Microsoft PowerPoint, Microsoft Word, Microsoft Excel

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Responsible for planning and submitting the simple EUCTR submissions i.e. Phase I initial submissions, Mono national initial submissions, substantial and non-substantial modification submission etc. CORE JOB RESPONSIBILITIES: Collaborate with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies. Engage with Regulatory Affairs functional representatives to plan the part-II Clinical Trial Application (CTA) for EU countries. Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database. Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database. Collect the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database. Liase with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions. Monitor and report on the progress of Part II activities to ensure alignment with overall trial timelines and objectives. Ensure part-II CTA comply with national regulatory requirements in each member state where the trial is conducted Triage any questions that surface (Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications and work with relevant stakeholders to have RFI responses generated. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submission and ensure all collected documents comply with the IVDR country requirements. Ensure that all trial-related documents are archived in compliance with regulatory requirements and company policies. Identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold/restart/cancel dates that may apply to the study and capture the relevant dates within the CTIS database. Maintain and manage the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization. Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR Level I Interpersonal & leadership skills Ability to understand and implement the operational strategic direction and guidance for respective clinical studies A data driven approach to planning, executing, and problem solving Effective communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to build productive study teams collaborations Vendor management experience Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel Experience in the clinical drug development process, including study start-up Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines Basic project management skills, cross-functional team interaction and organizational skills May require up to 25% travel Bachelor’s degree and 1-2 years of relevant experience. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The role involves planning and submitting clinical trial applications within the EUCTR framework while collaborating with cross-functional teams to manage study milestones. Responsibilities also include maintaining accurate data in the CTIS database and ensuring all trial-related documentation complies with national and international regulatory requirements.