Study Start-Up Specialist
Milano, IT
Job Purpose
We're expanding our Clinical Operations team and are looking for a Study Start-Up Specialist to join us! This is an exciting opportunity to contribute to the timely and efficient initiation of clinical trials, ensuring all regulatory and operational requirements are met.
As a Study Start-Up Specialist, you will play a crucial role in the initial phases of our clinical trials. You'll be responsible for a variety of tasks, from regulatory submissions to site activation, ensuring meticulous documentation and adherence to global standards.
Key Responsibilities
- Regulatory Submissions: Prepare, review, and submit essential regulatory documents to ethics committees and regulatory authorities.
- CTIS Submissions: Utilize your working knowledge of the CTIS platform for submissions.
- Submission Quality Control (QC): Perform timely and accurate quality control checks on documents for initial study submissions and amendments.
- Site Activation: Support the comprehensive site activation process.
- CRO Oversight: Monitor and manage CRO performance in collecting required documents, ensuring adherence to quality standards and timelines.
- Document Management: Ensure all essential documents are collected, reviewed, and filed in compliance with regulatory requirements and company SOPs.
- Greenlight Pack Review: Conduct thorough reviews of greenlight pack documents to ensure all necessary approvals are in place before site activation.
- Translations Management: Coordinate and manage translations of study documents as required.
- Feasibility Support: Assist the Study Start-Up Manager with feasibility activities, including preparing feasibility packages and managing the process within Veeva SSU suite.
- CTMS Management: Maintain and update the Clinical Trial Management System (CTMS) with all milestones and dates, ensuring accuracy and timeliness.
- CRO Support: Provide support to CROs for any issues related to the use of Veeva SSU.
- Study Notifications: Handle study notifications where necessary.
- Operational Support: Provide comprehensive operational support to the Study Start-Up Manager across all start-up activities.
- Quality Control: Conduct quality checks on start-up documents and processes to ensure accuracy and compliance.
- Collaboration: Work closely with start-up study functions, clinical study managers, CRAs, regulatory affairs, and other stakeholders to ensure smooth study initiation.
Required Education
Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
Required Skills and Experience
- Minimum of 3+ years of experience in clinical trial start-up activities within the pharmaceutical or CRO industry.
- Solid background in Clinical Operations and/or Study Start-Up activities.
- Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Strong operational skills and a demonstrated ability to meet timelines.
- High level of accuracy and meticulous attention to detail in managing documentation.
Technical Competencies
- Good knowledge of Veeva systems, specifically CTMS and eTMF.
- Good knowledge of CTIS and IRAS.
- Experience reporting project details to various internal and external stakeholders.
- Ability to identify and resolve issues related to study start-up activities.
- Knowledge of MDR (Medical Device Regulation) is a plus.
Required Behaviours and Competencies
- Excellent communication skills and proven ability to work effectively within a cross-functional team.
- Ability to work within multidisciplinary teams and coordinate internal and external stakeholders (CROs/vendors).
- Proven aptitude for problem-solving and decision-making.
Required Languages
Fluent in English.