Clinical Operations Lead

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden the Netherlands with an office in and Cambridge Massachusetts USA.

At ProQR we are on a mission to edit RNA treat disease and change lives. A team of 180 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is committed to pioneering transformative RNA therapies to make a difference in the lives of the communities we serve.

Our proprietary Axiomer RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA) a protein which is present in all human cells to repair G-to-A mutations modulate protein and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases. By harnessing the power of RNA editing we aim to create a world where genetics inform your health - but never limit it.

Our Development Department is currently looking for a Clinical Operations Lead (Full-time) to join our team. The Development Department advances drug candidates from early research into clinical testing ensuring they are thoroughly evaluated for safety and efficacy. Translational Development generates the data needed to move programs into the clinic while Clinical Development designs and executes trials to demonstrate safety and efficacy in patients. Together they connect science medicine and regulatory strategy to drive successful therapeutic development.

As a Clinical Operations Lead you will serve as the operational leader of the clinical trial team and play a pivotal role in the successful execution of clinical studies. You are responsible for the end-to-end management of outsourced clinical trials and act as the primary point of contact between the organization and external service this role you ensure that assigned clinical trials are delivered in line with agreed timelines budgets and operational and quality standards while fully complying with applicable laws and regulations. You proactively identify assess and mitigate operational risks throughout the entire clinical trial lifecycle. You will provide hands-on oversight to safeguard data integrity and patient safety including activities. Additionally you are responsible for the set-up ongoing maintenance and overall quality of the Trial Master File for assigned studies.

This position offers the opportunity to work cross-functionally drive operational excellence and make a meaningful impact on the delivery of high-quality clinical research.

Location: Leiden NL (on-site)

We expect our Clinical Operations Lead to have:

• Minimum Bachelors degree in a life science-related field; Advanced degree in a health-related field is preferred

• Minimum 5 years of experience as Clinical Operations Lead in the management of global clinical trials with a proven track record of managing outsourced clinical trials and CRO oversight.

• Excellent knowledge of the ICH-GCP guidelines and the relevant EMA/FDA regulations and the clinical development process.

Additional requirements:

• Experience in Phase 1-2 clinical trial management

• Experience in selecting and managing External Service Providers (ESP) including qualification set-up project management oversight performance assessments and finance management

• Previous experience working with EDC eTMF CTMS systems; knowledge of some widely used eTMF/CTMS systems in multi-center multi-national trial settings (e.g. Veeva Vault Medrio Medidata Rave ClinSpark etc.) is an advantage

Skills and competencies that are required for making the difference:

Hands-on mentality

Teamplayer

Able to work in a fast-paced environment

Strong project planning and management skills

Able to prioritize multiple tasks

Critical thinking decision-making and problem-solving skills

Excellent communication skills

Pro-active and pragmatic self-starter with a result-oriented mindset

ProQR as an employer

As an employer we value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. We believe that when people are happy energized and supported by an environment in which they can thrive they can achieve extraordinary things.

We are committed to ensuring 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 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:

• 8% holiday allowance

• 30 vacation days

• An annual performance bonus

• Stock options

• A premium-free pension plan

• A commuting allowance

• A subsidized staff restaurant

• Unlimited (un)healthy snacks and drinks

• Employee events (boot camp Coffee and Collaboration Café and other social events)

We are looking for people who are inspired by our mission to edit RNA treat disease and change lives. Are you up for the challenge

Submit your application via the Apply button below. Please contact Silvia Catellani via if you have any questions.

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