Clinical Compliance Operations Manager
2 months ago
- Track and monitor progress of department action items related to inspection readiness activities
- Contribute to activities related to department standardization of execution with Clinical Research Organization (CRO) partner(s)
- Generate, review and share various Key Performance Indicators (KPIs), Key Quality Indicators (KQIs) and other metrics e with key department members
- Assist with system access management activities for electronic Trial Master File (eTMF) system
- Assist with identifying potential process gaps and opportunities for improved efficiencies and risk mitigations
- Track the creation of new or revisions of existing controlled documents (e.g., SOP, Work Instructions)
- Assist with eTMF report generation and conducting TMF completeness activities
- Assess potential process updates based on ICH E6, r3 updates
- Other department tasks, as needed
Requirements
- BS/BA degreed discipline and 3 years of related experience
- Knowledge of TMF-related activities, including CDISC-TMF Reference Model
- Knowledge of the drug development process including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) requirements
- Understanding of the clinical trial stages, such as study start-up, maintenance, and closeout
- Experience with a growing biotechnology company
- Ability to work independently and collaboratively with internal teams in a fast-paced, multi-disciplinary team environment
- Solid communication skills
- Proficient in the use of the Microsoft Office Suite
- Experience with PhlexTMF and Veeva QMS a plus
Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.\r
\r
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/\r
\r
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
-
Compliance and Training Manager
4 months ago
Remote, United States Partners In Health Full timePosition Overview : Partners In Health (PIH) is looking for a self-motivated, detail-oriented Compliance and Training Manager with experience in contracts and grant management within the nonprofit sector that includes working with public sector or other high-compliance donor-funded awards. The position requires strong cross-cultural acumen and superb...
-
Senior Global Clinical Operations Lead
2 weeks ago
Remote, United States INSPYR Solutions Full timeTitle: Senior Global Clinical Operations Lead Location: Remote Duration: 6+ months Compensation: $85.00 – 87.00/hr Work Requirements: US Citizen, GC Holders or Authorized to Work in the U.S. Senior Global Clinical Operations Lead The Senior Global Clinical Operations Lead is responsible for the delivery of a clinical study or studies in accordance with...
-
Energy Programs Manager
1 month ago
Remote, Oregon, United States Stem US Operations Inc. Full timeJob Title: Sr. Energy Programs Manager, CAISOStem US Operations Inc. is seeking a highly skilled and experienced Sr. Energy Programs Manager to join our team in San Francisco, CA. As a key member of our Grid Services Program Management team, you will be responsible for building, executing, and measuring the performance of our market operations in North...
-
FSP Senior Training and Compliance Partner
2 weeks ago
Remote, United States Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel has an exciting opportunity for a FSP Senior Training and Compliance Partner in the US ! This is a 100 % remote position with competitive salary and benefits! JOB DESCRIPTION FSP Senior Training and Compliance Partner Job Purpose: The FSP (Functional Service...
-
Product Associate, Clinical Products
5 days ago
Remote, United States Lightbeam Health Solutions Full timeJob DescriptionJob DescriptionThis job may be performed remotely with some travel.JOB SUMMARY:Transform healthcare like never before, closing care gaps, minimizing risk, improving quality of care and quality of life and making a true difference. Lightbeam’s proven, population health management platform transforms disparate data into a full 360-degree...
-
Business Partner Compliance Specialist, Americas
4 weeks ago
Remote, United States Solventum Full timeThank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...
-
Sales & Operations Manager, Retail
3 months ago
Remote, United States Numotion Full timeSales Remote, United States • ID: 13630-128 • Full-Time/Regular By joining Numotion, you will be a part of the nation's leading provider of Complex Rehabilitation Technology. Numotion is helping thousands of people with individually configured, medically necessary mobility products and services. From manual and powered wheelchairs to disposable...
-
Manager of Biomedical Technical Services
1 month ago
Remote, United States Innovative Renal Care Full timeManager of Technical Services Location: Remote with travel to Virginia & South Carolina The Manager of Technical Services (MoTS) is a key leadership role accountable for overseeing the coordination of biomedical technical and facility services across multiple dialysis clinics. This position requires extensive expertise and a high degree of judgment to...
-
Clinical Contact Center Supervisor
4 weeks ago
Remote, United States Inizio Engage Full timeInizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses. This is your opportunity to join Inizio Engage and represent a top biotechnology company! What’s in it for you? Competitive compensation Excellent Benefits – accrued time off,...
-
Manager of Biomedical Technical Services
2 weeks ago
Remote, United States Innovative Renal Care Full timeManager of Technical Services Location: Remote with travel to clinics in New York, New Jersey, Delaware, Maryland, Washington DC, and Eastern Pennsylvania The Manager of Technical Services (MoTS) is a key leadership role accountable for overseeing the coordination of biomedical technical and facility services across multiple dialysis clinics. This...
-
Remote, United States DirectEmployers Full time**Job Description Summary**GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter where Healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a...
-
Clinical Client Account Manager
4 weeks ago
Remote, United States Inizio Engage Full timeInizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.The Client Account Manager, accomplishes project objectives by planning, evaluating and improving project specific activities. The Client Account Manager has responsibility for the day to day relationship...
-
Senior Manager, IT Infrastructure Operations
1 month ago
Remote, United States Percepta Full timeSenior Manager, Infrastructure OperationsAt Percepta, we bring first-class service across each market we support. As a Senior Manager, Infrastructure Operations, you'll be a part of creating and delivering amazing customer experiences, while also enjoying the satisfaction of being part of a unique culture.What You'll Be Doing The Senior Manager,...
-
Compliance Auditor
4 weeks ago
Remote, United States Yardi Systems, Inc. Full timeYardi is a global software company providing innovative property management solutions and services in every real estate market. We are focused on providing our customers with superior products and outstanding customer service. We are passionate about technology and believe work should be fulfilling and fun! We are committed to our customers, employees and...
-
Corporate Safety
2 weeks ago
Remote, United States The Bright Hospitality Management Full time*Overview*The Bright Hospitality Management is looking for an experienced, organized, and confident Corporate Safety & Security Manager to join our fast-growing team and be a key part of the leadership. The Corporate Safety & Security Manager is responsible for developing and implementing security policies, strategies, and procedures to protect the...
-
Corporate Safety
4 weeks ago
Remote, United States The Bright Hospitality Management Full time*Overview*The Bright Hospitality Management is looking for an experienced, organized, and confident Corporate Safety & Security Manager to join our fast-growing team and be a key part of the leadership. The Corporate Safety & Security Manager is responsible for developing and implementing security policies, strategies, and procedures to protect the...
-
Fractional Accounting Manager/Controller
4 weeks ago
Remote, United States Recruiting Firm - Client Company Part timeJob DescriptionJob DescriptionRemote Fractional Accounting Manager/Controller - Premium Wine BrandOur client, a premium wine brand, is seeking a remote, part-time Accounting Manager/Controller. This role will oversee all aspects of financial management for the company, including accounting, financial reporting, budgeting, forecasting, and compliance. This...
-
Senior Project Manager
2 days ago
Remote, United States Security Cleared Jobs Full timeJob Description Summary• The business is adding new customers, expanding into new geographies, and developing new technology. The Senior Project Manager will support projects that are typically executed using an EPC (Engineering, Procurement and Construction) or an Engineered Equipment Package (EEP) contract framework. The Project Manager will deliver...
-
Clinical Specialist
1 month ago
Remote, Oregon, United States Midi Full timePosition OverviewWe are seeking a subject matter authority in the care of women in midlife to join our telehealth practice as a clinical moderator for questions and escalations.This role will report to the Medical Director and be responsible for continuous improvement in patient care through supporting our clinicians.ResponsibilitiesModerate Clinical Slack...
-
Remote, United States Highlights Healthcare Full timeHighlights Healthcare ABA is seeking a passionate Clinical Supervisor - BCBA/LBA to join our growing team for this hybrid role located in North Carolina. If you are someone who puts the client first and is adaptable to their evolving needs, then you are a great fit for our Highlights family.As a Remote Clinical Supervisor (BCBA) at Highlights Healthcare, you...