With the RNA molecule as the basis of their novel drug discovery platform, they are targeting an unprecedented range of therapeutic areas. Their antisense therapies are disrupting diseases and changing their course – from the rarest of conditions to those that impact millions of people. They currently have three commercial products and more than 40 potentially transformative medicines in the pipeline designed to treat a broad range of diseases.
We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
The Clinical Trial Manager (CTM) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials for ongoing study in patients with Alexander Disease.
CORE RESPONSIBILITIES
- Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
- Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes
- Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
- Support phase 1-3 multiple ascending dose in US, Canada, AUS, Europe, and Japan
- Collects and reviews essential documents from Investigational sites
- Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
- Participates in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation
- Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
- Assists in the development of study materials, case report forms (CRFs), informed consent documents for clinical studies
- Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
- Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
- Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs)
- Keeps the Clinical Project Lead (CPL) informed of the progress of projects
- Develops and maintains good working relationships with Investigators and study staff
- Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
- Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
- Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
- Ensures timely study entry and updates to ClinicalTrials.gov
- Assists with the design and preparation of study related materials for the training of internal and external staff
- Participates in co-monitoring activities and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring and closeout visits
- Assists with the tracking and management of study specific budgets
- Participates in the development of departmental processes, SOPs, and initiatives
- Assists with facilitating the resolution of data queries and requests from Clinical Data Management
- Travel is variable and estimated at 5%
- Ability to work in a team or independently as required
- Effective written and verbal communication skills
- Critically evaluates job tasks and the impact on overall trial management objectives
- Sound problem-solving capabilities
- Good judgment in triaging issues from internal and external customers
- Effectively collaborates with Clinical Trial Team members
- Outstanding organizational skills with the ability to multi-task and prioritize
- Exceptional attention to detail
- Proven flexibility and adaptability
- Bachelor’s Degree preferred
- Minimum of 7 years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
- Experience in neuro and/or complex study design management would be a plus
- Experience in scientific discipline and multiple therapeutic areas preferred
- Experience with complex study in rare disease. Double-Blind and Sham Controlled, Randomized, Placebo-Controlled study
- Experience in drug development
- Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; ss21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
- Proficiency in MS Office including Word, Excel, PowerPoint
- Occasional travel needed each year