Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.
We promote a trusting and appreciative company culture and value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.
Requirements
- BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) or relevant industry experience in lieu
- Minimum 3 years of experience within clinical operations or similar field
- Knowledge of clinical trial documentation and regulatory requirements related to trial master files is preferred
- Ability to communicate and collaborate respectfully
- Decision making abilities, but knows when to ask for advice
- Structured and organized with excellent attention to detail
- Proactively identifies problems and generates possible solutions to present to a team
- Eager to learn and balance multiple tasks simultaneously
- Excellent writing and communication skills
- Experience using MS Office Suite (Excel, Word, PowerPoint)
- Comfortable presenting ideas to a group
- Oncology experience preferred
- Ensure completeness, accuracy, and quality of the Trial Master File (TMF) for allocated trial(s) according to internal SOPs and procedures (TMF Manager), including filing documents and performing QC checks as needed
- User administration (internal and external) management for clinical IT systems used in allocated trial(s) according to internal procedures
Support the Clinical Trial Manager and clinical study team with administrative aspects of clinical trial execution such as setting up meetings, capturing/reviewing minutes, maintaining Actions/Decisions/Issues (ADI) Log, creating presentations, routing documents for review and signatures electronically
Key Responsibilities
- Receive clinical study documents from study team, sites or vendors, review for completeness, accuracy, and expiration and file to the TMF
- Support maintenance of the TMF and assist in quality control as appropriate, including review for missing, duplicates, and expiring documents according to SOPs and procedures
- Support maintenance of the Clinical Trial Management System (CTMS) for allocated trial(s) according to SOPs and procedures, including performing QC checks as needed
- Maintain a contact and training lists of all trial related personnel (internal and external) or coordinate and oversee these activities if outsourced to a CRO
- Create, review, and remove internal and external users in selected trial related systems or collaborate with relevant CROs to ensure user administration is performed according to internal and external requirements
- Establish and maintain tracking tools for assigned trials
- Distribute clinical trial related materials to sites or clinical team members
- May act as a central contact for designated project communications, correspondence, and associated documentation
- Participate in team meetings and assist in preparation of agendas, minutes, and tracking of action items
- Assist in the creation of study materials, including but not limited to documents, presentations, and reports
- Perform administrative tasks to support Clinical Operations Department and team members as needed, including routing documents for signatures in Veeva or with DocuSign
- Train and support trial team members, sites, and vendors in review of clinical trial documents for legibility and accuracy in accordance with SOPs, the protocol, and appropriate regulations
- Train and support trial team members in Ascendis’ eTMF system and Veeva Document Vault
- Support and participate with eTMF expertise during audits and inspections
- Find, order, distribute, and track distribution of non-IMP related ancillaries and other clinical trial related materials to clinical sites; or coordinate and oversee these activities if outsourced