Clinical Contract Specialist
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Clinical Operations department is currently looking for a Clinical Contracts Specialist (Full-time) to join our team.
The Clinical Contracts Specialist is responsible for supporting clinical trials by providing management and oversight of the clinical study contracts process, including the flow of clinical trial agreement lifecycles, negotiating clinical site budgets, and for ensuring that study deliverables are completed on time, with a high degree of quality, and in accordance with industry standards. This position will work closely with stakeholders such as clinical study teams, clinical project managers, the Legal department, and clinical study site personnel and will report into the VP of Clinical Operations.
- Lead the processes to secure clinical site contracts and other associated site based legal documents (e.g. confidentiality agreements, indemnity agreements, funding agreements, equipment loan agreements).
- Manage the study site budget process from country template stage to fully negotiated site contracts and associated amendments. Includes utilizing benchmarking techniques to develop industry standards templates and budgeting expectations.
- Serve as a main point of contact with Contract Research Organizations (CROs) when CROs are managing and negotiating site budgets on behalf of ProQR
- Develop and review legal site contract parameters for CRO to work within, and maintain oversight of CROs timelines and deliverables
- Analyze site contract trends and develop metrics in an effort to uncover site contract bottlenecks and improve on overall site start up times
- Work with internal and external stakeholders to identify, evaluate, and implement opportunities to improve processes or develop new initiatives that will add value to the site contracting process
- Conduct contract quality control and remediate as needed
- Serve as a main point of contact with the Legal department, working collaboratively to ensure that the Legal Department are made aware of priorities, arising trends, timelines and key issues
- Work collaboratively with the clinical study teams to understand and input into start up timelines, highlighting risks and opportunities when applicable, and ensuring clinical contract deliverables are met
- Develop and manage the contract/budget escalation process within Clinical, Legal and Senior Management when appropriate
- Provide regular, clear, status reports on contract/budget negotiation, finalization and signature to appropriate study teams and the VP of Clinical Operations
Location: Leiden, NL or Cambridge, Massachusetts, US or remote
We expect our Clinical Contract Specialist to have:
- Have a B.A./B.S. degree; life sciences is preferred
- At least 4 years of working experience preferably within the Biotech / Pharmaceutical industry
- experience with working with Investigator site contracts and budget processes
- proven affinity in building relationships with Investigative suites and negotiating contracts and budgets
- excellent knowledge of ICH/GCP
- the ability to work independently in a fast paced environment
Skills and competencies that are required for making the difference:
- Analytical and accurate
- Hands-on mentality
- Pro-active attitude
- Being able to work in a fast pace environment
- Being able to prioritize multiple tasks
- Excellent communication skills
- Pro-active and pragmatic self-starter, with a result-oriented mindset
- A nice person
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.