(Senior) Clinical Trial Manager

GRANITE BIO is seeking an (Senior) Clinical Trial Manager.

GRANITE BIO is a recently established biotechnology company within the Ridgeline Discovery incubator (www.ridgelinediscovery.com) located in Basel (Switzerland). Based on fundamental research conducted over the last two decades, GRANITE BIO is pursuing a differentiated approach impacting central disease biology nodes to transform inflammatory, autoimmune, and fibrotic conditions.

The Clinical Trial Manager (CTM) / Senior CTM (sCTM) will support all areas of clinical trial execution including, but not limited to, managing day-to-day activities from start-up to closeout and CRO/ vendor oversight. This position will report to the Head of Clinical Operations. The CTM/sCTM will play a key role in working cross functionally, ensuring timely achievement of study milestones according to project goals and in compliance with SOPs, local regulations, CFR, ICH, and GCP guidelines.

The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.

RESPONSIBILITIES

• Management of the relationship with vendors/CROs providing oversight and guarantying compliance with the protocol and other study documents, SOPs, regulatory requirements, and quality standards.
• Planning, implementation and oversight of the trial budget and vendor’s invoices.
• Review of study documents and working procedures and training of clinical study team.
• Tracking of key trial activities and milestones to ensure adherence to the study plan and to timely identify, evaluate, and rectify problems.
• Work cross functionally with internal project team members aligning deliverables, timelines, and responsibilities.
• Liaising with CRO/vendor and study sites to ensure clinical data are kept up-to-date and accurately completed.
• Maintenance and quality control of the sponsor and site TMF.
• Preparation of clinical trial team meetings and minutes.
• Supporting/ensuring clinical trial risks/issues continuous assessment and respective adherence to the Quality Management System.
• Management of clinical trial risks/issues identified and implementation of mitigation strategies.
• Implementation of innovative processes to optimize trial execution.

WHO YOU ARE

• BSc in biological science or a related field.
• 3+ years of experience in clinical trial operations (sponsor side experience preferred).
• Exceptional organizational skills and ability to prioritize tasks in a fast-paced environment.
• Analytical and critical thinking with strong focus on quality and compliance.
• Motivated team player with excellent communication and interpersonal skills and the ability to effectively collaborate with internal and external stakeholders.
• Good knowledge of GCP guidelines and regulatory requirements (e.g EMA, FDA).
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Preferred: background in biologics and Ph1/2 trials.
• Preferred: Basel area based.

WHAT WE CURRENTLY OFFER

• Offices: Our well-equipped laboratories and offices are located at the Tech Park, a premier address for early-stage start-ups in Basel.
• Commuter Benefits: We support our employees tailored to their personal needs in commuting to work and offer parking facilities or a commuter contribution.
• Flexible Working: We support flexible working as appropriate.
• Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
• Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
• Food: We like get-togethers during lunch time. Enjoy tasty, subsidised meals from our FELFEL food fridge.
• Coffee: Meet up with your colleagues and grab free coffee.
• Development: We support the individual development of our employees.
• Creativity: We offer an innovative and creative environment.
• People: We are an international and diverse team with talented and passionate people.
• Fun: From time-to-time we organise cool off-site summer and winter team events.

To apply, please send us this application form together with your CV, Cover Letter and Reference Letters (Arbeitszeugnisse).