About the role
The Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan. They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.
Under guidance of senior team members, independently manages study start-up activities for projects of low complexity, ensuring effective coordination and delivery of assigned.
Prepare, collect, review regulatory information to support submissions to national authorities and ECs/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines.
Responsible for site outreach in assigned country/countries; point of contact for site, sharing of non-confidential and confidential study information and management of confidential disclosure agreements
Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to site activation readiness investigational product release, site activation and site initiation.
Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements
Arrange for and/or review translation of essential documents as required
Contributes to the development of regulatory and study start-up strategies and supports preparation of SSU plans and related documentation
Ensure timely and accurate completion of project trackers, filing in study portal and TMF, and QC of submission dossiers
Ensures assigned deliverables are completed in accordance with project timelines and expectations.
Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
Previous experience within the pharmaceutical/CRO industry
Good knowledge of ICH GCP and national regulations for territories of competency
Good written and verbal communication skills to clearly and concisely present information
Proficiency in English, both written and verbal
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Originally posted on Himalayas