Associate Manager, Clinical Safety Operations
Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime.
Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep.
Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.
Summary :
The Associate Manager, SafetyOperations reports to the Sr. Manager, Clinical Safety Operations andPharmacovigilance and is responsible for being the functional representative for clinical safety operations for all Apnimed sponsored clinical trials, including vendor oversight.
This role is responsible for overseeing day-to-day processes and communicating status to senior management, as appropriate.
This is an exciting opportunity to be at the forefront of a major paradigm shift in the treatment of sleep apnea from medical devices and surgery to a first in class pharmaceutical treatment.
Key Job Duties include, but are not limited to :
- Oversee Safety Operations vendors for all Apnimed-sponsored clinical trials, including day-to-day oversight, review, and evaluation of vendor performance, reporting requirements, and quality.
- Monitor Key Performance Indicators (KPIs) and compliance metrics from the Safety Operations vendor, and track trends or potential improvements.
- Support the initiation of clinical safety services for Apnimed-sponsored studies, including reviewing contracts for accuracy.
- Responsible for overseeing the Safety Management Plan (SMP) for each Apnimed-sponsored study, either directly or through oversight and participate in creation of other essential study documents.
- Monitor and ensure regulatory submission compliance for clinical safety submissions.
- Ensure all relevant documents are submitted to the Trial Master File in accordance with company SOPs and sponsor requirements for clinical trials.
- Participates in study team meetings
- Acts as the Functional Lead representative for Safety Operations for all Apnimed sponsored clinical trials.
- Start up, manage, and close out clinical trials with functional oversight for Safety Operations.
- Contributes to regulatory inspections and audits as a subject matter expert for clinical safety activities.
Education and Experience :
- BS degree (preferably in nursing, pharmacy, or other health care or life sciences related profession) and a minimum of 4-7 years of drug safety experience preferably in a pharmaceutical company or an equivalent combination of education and experience.
- Comprehensive knowledge of GCP guidelines.
- Proven ability to lead and manage drug safety activities independently
Skills :
- Ability to manage simultaneous priorities and changing deadlines.
- Ability to plan, organize and prioritize work.
- Strong initiative, strong organizational and time management skills
- Well-developed analytical thinking combined with a high sense of responsibility and accountability.
- Must work effectively / collaboratively in a fast-paced cross-functional team environment.
- Communication Skills : Excellent verbal and written communication skills to effectively convey safety information and collaborate with stakeholders.
- Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional.
What Apnimed Offers :
- 401(k) with companymatch
- Generous time off for vacation
- Generous healthcare benefits
- Flexible working environment
- Motivated and experienced team
- Winner of 2024 Boston Business Journal Best Places to Work
Sr. Clinical Trial Manager, Clinical Operations, Therapeutics
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate. Lead the Clinical Trial Team, and support other development teams as a Clinical Operat...
Associate Director, Clinical Operations
The Associate Director, Clinical Operations is the operational leader of the Trial Team and will closely partner and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver trials according to plan and while ensuring quality in accordance with FDA, ...
Safety Manager
OSHA including the 300 logWorkers CompensationSafety reporting to insurance carriersClaims reviewKPI’s and Safety number reportingNear miss reporting Routinely conducts inspections and audits of all operations for work conditions, work practices and operational behaviors to ensure that safety-relate...
Lab Operations and Safety Manager
The Laboratory Operations and Safety Manager will report to the Senior Business Manager of the Chemical Engineering department and work closely with the Associate Director of Lab Operations. Serves as the principal liaison with COE Associate Director of Academic Operations, COE Associate Director of...
Associate Manager, Creative Operations
The Associate Manager, Creative Operations reports to the Director of Creative Operations and is responsible for the day-to-day project management and traffic flow of CORE and line extension print and digital projects. The Associate Manager, Creative Operations will ensure that all work is assigned ...
Clinical Trial Manager
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role. Accountable for project related efforts for the delivery of studies ...
F&B Operations Manager
The ideal candidate must have a minimum of 2 years in hospitality operations management. ...
Clinical Trial Manager, Start Up
Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-p...
Clinical Trial Manager
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role. Accountable for project related efforts for the delivery of studies ...
Clinical Research Associate Manager---Cancer Center Protocol Office
The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management. Clinical Research Associate Manager...