Study Start-Up Specialist
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.
- 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.
- 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.
- 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.
- 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.
At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.