Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Senior Clinical Trials Manager

Expired Job

Apex Systems, Inc. Seattle , WA 98101

Posted 4 months ago

Description Apex Life Sciences is looking for an Sr. CTM to serve a commercial stage bio-pharmaceutical company in Seattle!

The ideal candidate MUST have 8+ years of sponsor experience. This is a Full-Time, Permanent opportunity. For immediate consideration, please send resumes to:

Position Summary: The Sr. Clinical Trials Manager (CTM) works closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates. Essential

Duties & Responsibilities:

Manages the operational aspects of clinical trials Manages Clinical Operations personnel Manages the study project plan, including timeline, budget, and resources Participates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate Prepares metrics and updates for management, as assigned Proactively identifies potential study issues/risks and recommends/implements solutions Participates in and facilitates CRO/vendor selection process for outsourced activities Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files) Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines) Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations Participates in the development, review and implementation of departmental SOPs and processes Recommends and implements innovative process ideas to positively impact clinical trials management Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings Serves as a liaison and resource for investigational sites Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function Performs some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as needed Experience and Education Required: A 4-year degree from a university with a related degree in a Life Science 8+ years of related clinical trial management experience with a minimum of 2 years of supervisory experience Experience in interactions with outside vendors, e.g., CROs and other vendors Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines Able to deal with time demands, incomplete information or unexpected events Able to provide clinical operations expertise to clinical development in a specified product areas and projects Able to travel approximately 10% overnight (50% or greater during peak times) Behavioral Competencies Required:

upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Clinical Trials Management Associate Oncology

Gilead Sciences, Inc.

Posted 4 weeks ago

VIEW JOBS 12/18/2018 12:00:00 AM 2019-03-18T00:00 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Specific Responsibilities and Skills for Position: * Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas * Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs * Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management * Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies * Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations * Assist the CTM to organize and lead review/approval meetings for CO proposal * Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions * Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions * Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams * Able to anticipate obstacles and proactively develop solutions to achieve project goals * Develop a general understanding of functional issues and routine project goals from an organizational perspective * Participate in abstract presentations, oral presentations, and manuscript development activities * Interact and cooperate with individuals in other functional areas to address routine study issues * Develop tools and processes that increase measured efficiencies of the project * Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs), * For GS studies, assist in selecting Contract Research Organizations (CROs) or vendors * Assist with the setting and updating of study timelines * Participate in departmental, or interdepartmental, strategic initiatives under general supervision * Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies * Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits * Ensure that the site complies with the protocol and regulatory requirements for GS studies * For GS studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans * Travel may be required Knowledge: * Excellent verbal, written, interpersonal and presentation skills are required * Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies * Working knowledge and experience with Word, PowerPoint and Excel Experience and Skills: * At least 3+ years of experience and a BS or BA in a relevant scientific discipline * At least 3+ years of experience and an RN (2 or 3 year certificate) For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. Seattle WA

Senior Clinical Trials Manager

Expired Job

Apex Systems, Inc.