Trial Master File (TMF) Manager
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 Trial Master File (TMF) Manager (Full-time) to join our team.
The TMF Manager
Is responsible for the day-to-day management of ProQR’s Trial Master File (TMF), that may be maintained in-house or outsourced to a third party vendor. Responsibilities include oversight of the review and approval of TMF documents and generation of reports to measure completeness, accuracy and timeliness of the TMF. This role has a strong focus on ensuring that document management operations are performed with adherence to standard operating procedures (SOPs) and ICH GCP/regulatory guidelines and ensuring the TMFs are inspection ready at all times.
- Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, meets quality and timeline metrics
- Serve as subject matter expert (SME) on the management of the TMF; contribute to the development and assist with the implementation of TMF specifications, such as process and system changes.
- Assist with inspection/audit related activities (e.g., preparation, correction action plans)
- Participate as a TMF SME during audits and inspections, interact with auditors and inspectors to address queries; support the preparation of appropriate audit and inspection responses.
- Conduct periodic TMF reviews for completeness and quality to provide recommendations, and guidance to support resolution of TMF findings.
- Ensure quality checks are performed as per SOPs and monitor progress in resolution of identified TMF discrepancies.
- Liaise with 3rd party vendors assigned to, or contribute to, TMF management, and ensure quality deliverables are met in accordance with vendor contracts and ProQR expectations
- Monitor and review performance management of direct report; conduct regular one-to-one meetings to discuss performance employing coaching and mentoring skills, constructive criticism, and help with goal setting and management through empowerment and motivation techniques.
- Support department growth by developing and maintaining process improvements (SOPs, work instructions, TMF plans, etc.)
- Prepare and/or determine standards for the organisation’s TMF best practices and lead/participate in TMF process improvement initiatives
- Maintain up-to-date knowledge of the TMF Reference Model, industry best practices and regulatory considerations.
- Propose and collaborate on department initiatives and strategies.
- Lead team meetings as appropriate.
Location: Leiden, NL or Cambridge, Massachusetts, US or remote
We expect our Clinical Contract Specialist to have:
- Have a B.A./B.S. degree or equivalent; life sciences is preferred
- At least 4 years of working experience preferably within the Biotech / Pharmaceutical industry
- Excellent knowledge of ICH and FDA GCP guidelines related to clinical document management
- Understanding of the clinical trial process, experience in handling clinical trial related documents required
- Strong organisational skills with outstanding attention to detail and follow through
- 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 Yessica de Brouwer via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.