Specialist Study Start Up & Regulatory Affairs

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

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.

Medicine moves forward here. So will you.

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

Originally posted on Himalayas