Site Manager

Company Description

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.

Job Description

The Site Manager (SM) is engaged in facilitating the conduct of clinical studies. Specific focus is put on
patient related site support, with the aim to maximise the utilisation of site staff designated to a given
study (e.g. study site coordinator, study nurse, sub-investigator) through provision of site training and
oversight for logistically / technically more demanding study procedures. The SM is working under the
supervision of Senior SM or Director of Site Management (or LSM on project level).

Role and Responsibilities:

• Conducts patient related site support as per study specific site management plan
• Ensures the progress of the clinical study and that it is conducted, recorded, and reported in accordance with the protocol, Ergomed standard operating procedures (SOPs), ICH GCP, and the applicable regulatory requirement(s)
• Acts as primary contact with Study Site Coordinator (SSC)/Research Nurse (RN)
• Participating in SM trainings
• Ensures continuous training, consultation, support and supervision of SSCs
• Assists in development of patient recruitment and retention strategies, and tracking of recruitment activities at assigned investigational sites
• Oversees IMP and other clinical trial supplies inventory and facilitates logistics for the shipment of samples
• Notifies LSM / CRA / CTM / PM on any site issue that is detected in contact with the site
• Establishes and maintains relationships with SSCs/RNs, Investigators and Sub-Investigators to optimize performance on clinical studies
• Participates in internal team teleconferences and meetings related to general site management group activities, as required on project level
• Prepares Site Management Visit report after on-site/remote visit
• Ensures that SM visit reports, phone contact reports and any relevant correspondence is provided for filing in eTMF as per study specific Filing Plan
• Supports in management of patient travel expenses or other expenses, preparation of calculation sheets and assistance in site's invoicing.

Qualifications

• Educated to degree standard (preferably in medical / public health field) or appropriate equivalent work experience
• Previous experience in conducting site management/site support activities

Additional Information

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.