.Company DescriptionErgomed 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 high-quality client service can be achieved.Come and join us in this exciting journey to make a positive impact in patients' lives.Job DescriptionThe Specialist/Senior 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.DUTIES AND RESPONSIBILITIES:Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelinesare not reached, provide clear rationale for delays and contingency plans to mitigate impact.
Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently.Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethics Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.Collect, review for completeness and compliance, and track essential documents 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.Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and regulatory/EC submissions/approvals.Participate in ICF development, review, negotiation and approval processes.Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.Support feasibility, site identification and site documents customization (i.E.
informed consent document) as needed and closely follow up with investigative sites for updates/resolution