Site Contracts Manager

Due to the continued growth of our Global Study Start Up Group, we are now seeking a Site Contracts Manager who will be responsible for overseeing the negotiation process of clinical study agreements on assigned trials, and who will act as a subject matter expert to our sponsors and stakeholders in own countries of assignment.

The Site Contracts Manager will be responsible for (but not limited to) the following activities:

• Plan the Clinical Site Agreement (CSA) execution strategy for assigned studies in line with overall study start-up delivery plans and client expectations.
• Work closely with internal and external stakeholders to prepare the necessary Clinical Site Agreement templates, payment terms, as well as country budgets including fallback positions and negotiation parameters in line with Ergomed’s standards.
• Lead CSA negotiations on a study level and drive the finalization and execution of CSAs as per planned timelines.
• Negotiate directly with sites in countries of own assignment.
• Manage escalation of out-of-parameter contractual and budgetary requests to sponsor or internal decision-makers.
• Provide consultation during escalation of out-of-parameter queries as needed.
• Advise stakeholders on issue resolution within the context of assigned studies. Seek additional support from internal support structures as needed.
• Create and maintain document status reports’ and update department tools/systems and team members on a regular basis; Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
• Coordinate communications of all status updates to project team and sponsor.
• Manage site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
• Manage expectations of study team and sponsor study team regarding progress of global CSA negotiations for assigned studies.
• Participate in regular study calls to facilitate communication as needed.
• Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
• Collaborate with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Be accountable for Site Contracts delivery of assigned projects and/or initiatives.
• Act as a local SME in country of own residency / assignment.
• Perform other work-related duties as required by the Line Manager.

The ideal candidate will have:

• BS degree in law, business, life sciences, a health-related field, or equivalent combination of education and experience.

• Strong CRO operational experience with a track record of success in Site Contracts Management working in a local, regional, international or global capacity.

• Thorough knowledge of applicable regulations, drug development and clinical project management procedures.

• Understanding of specific country requirements pertaining to Site Contracts delivery in one or more countries (at least in own country of residence) and the ability to work across geographic regions.

• Ability to mentor and coach lesser experienced staff and supports SSU Management on all administrative or departmental activities.

• Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet.

• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

• Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor lesser experienced team members.

• Strong local contracting experience.

• Strong language skills in English and fluency in local language(s) required. Bulgarian, Czech, Hungarian and Serbian languages preferred.

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