Company Description
Ergomed PLC 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.
Job Description
Due to the continued growth of our Global Study Start Up Group, we are now seeking a (Senior) 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.
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.
- Organize and lead a CSA Kick off meeting with Ergomed staff assigned to CSA negotiations globally.
- 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.
- Perform other work-related duties as assigned.
* Please note we can consider candidates in the UK as well.
Qualifications
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 an international or global capacity.
- Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
- Understanding of the specific country requirements pertaining to Site Contracts delivery in one or more regions (but at least in the 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.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language.
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application!
