Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical
program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced
Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada.
Clinical Trial Manager
Reporting to the Senior Director, Clinical Operations, the successful candidate will manage clinical trial, registry and/or expanded access activities ensuring the timely completion of deliverables through development, management and oversight of the trial
CROs, timeline and budget.
Must be comfortable independently managing outsourced clinical trials with responsibilities delegated to CROs for activities such as, monitoring, site management, clinical supplies, data management, biostatistics, medical writing, safety, regulatory affairs
and quality assurance. In addition, the successful candidate will interact closely with investigators and site staff through routine calls and site sponsor visits.
Primary Position Responsibilities/Tasks:
Job responsibilities include, but are not necessarily limited to:
- Responsible for effective for effective global management of the study team and relationships with CROs, central labs, IRB’s, investigating sites and other external partners for multiple clinical trials. Coordinates the activities of all trial conduct partners
and team members and proactively identify and manage risks
- Participate in the development and/or review of all supporting documents for a clinical study – Investigator Brochures, Protocols, Informed Consent Forms, Study Operations Manuals, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study
Reports, for example
- Manage and lead cross-functional clinical trial team meetings collaborating with team members regarding operational activities pertaining to the execution of one or more clinical trial(s)
- Identifies investigational sites, participates in reviewing and approving qualified sites
- Create and review Request for Proposals, vendor specifications and participate in vendor selection process
- Manages the negotiation of contracts, budgets and timelines with CROs, clinical sites, and other external partners
- Review study invoices and manage accruals monthly
- Participates in the coordination of and training of team members and at investigator meetings
- Prepare and maintain assigned program files, study documentation and other regulatory documents
- Provide management with routine updates regarding the status of ongoing studies
- May participate in internal/external study related audits
- Ensure GCP compliance
- Ensure Trial Master File documentation is collected and completed contemporaneously
- Minimum BA/BS Degree
- Minimum 3-5 years of Clinical Trial Management
- Must be willing to travel, both domestic and international.
- Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH regulations and guidelines.
- Ability to provide appropriate leadership to clinical sites and CROs
- Detail-oriented individual with good problem-solving capability
- Global Expanded Access Program startup and management
- Strong multi-tasking, time management, and organizational skills
- Ability to take initiative and work both independently and in a team environment
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.