Clinical specialist Jobs in Worcester, MA
Last updated: 1 day ago
Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.Maintains a state of con...Show moreLast updated: 9 days ago
DWP seeks applicants for the position of a Compliance Specialist in its Andover, Massachusetts office.The Compliance department leads and guides DWP's efforts to comply with statutory and regulator...Show moreLast updated: 9 days ago
When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.The Regulatory Specialist supports regulatory compliance for clinical research at Bet...Show moreLast updated: 3 days ago
At Genworth, we empower families to navigate the aging journey with confidence.We are compassionate, experienced allies for those navigating care with guidance, products, and services that meet fam...Show moreLast updated: 30+ days ago
Tenet Massachusetts is seeking a Registered Nurse (RN) Clinical Support Specialist for a nursing job in Cherry Valley, Massachusetts.
Job Description & Requirements.By combining our advanced, state-...Show moreLast updated: 25 days ago
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count.
We are a commercial stage organ technology company, spun out of ...Show moreLast updated: 11 days ago
Baystate Health, a nationally recognized leader in healthcare quality and safety, and home to Baystate Medical Center (BMC), a Magnet Hospital for Nursing Excellence is looking for a Clinical Nurse...Show moreLast updated: 1 day ago
Tenet Massachusetts is seeking a Registered Nurse (RN) Clinical Support Specialist for a nursing job in Worcester, Massachusetts.
Job Description & Requirements.By combining our advanced, state-of-t...Show moreLast updated: 9 days ago
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena.Utilizing a re...Show moreLast updated: 1 day ago
Sirtex Medical is a global leader in healthcare, with offices in the U.Australia, Germany, and Singapore, dedicated to improving patient outcomes.
Our mission is to be at the forefront of minimally ...Show moreLast updated: 1 day ago
WSAudiology is a global leader in the hearing aid industry.Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions o...Show moreLast updated: 30+ days ago
Modivcare Personal Care Service, is looking for a.Care services such as supervising Caregivers / Certified Home Health Aides in a patient's home, evaluate the patient's plan of care and assess their ...Show moreLast updated: 1 day ago
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.As a Clinical Diabetes Specialist (CDS) you will partner with a Territory Business Leader...Show moreLast updated: 17 days ago
We are constantly looking to add to our core talent.If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is y...Show moreLast updated: 30+ days ago
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance.At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams ...Show moreLast updated: 1 day ago
The Women’s Health Clinical Account Specialist.Company's products, as well as education, and supporting clinical training programs.
They do this to support customer needs, to help the provider ...Show moreLast updated: 30+ days ago
The Clinical Specialist (CS) is a member of the nursing leadership team.The CS influences nurses, nursing support personnel and the organization to support evidence-based practice (EBP) and in coll...Show moreLast updated: 1 day ago
- Promoted
CLINICAL QUALITY COMPLIANCE SPECIALIST
LanceSoftMA, United StatesFull-time
- Promoted
COMPLIANCE SPECIALIST - CLINICAL AND BILLING
IWPMA, United StatesFull-time
- Promoted
REGULATORY SPECIALIST - STEPHENSON CLINICAL RESEARCH
Beth Israel Lahey HealthMA, United StatesFull-time
Claims Clinical Specialist – Medical Review Team
Genworth FinancialMassachusetts$124,600.00 yearly
Remote
Full-time
- Promoted
Registered Nurse (RN) - Clinical Support Specialist - $15+ per hour
HealthEcareers - ClientCherry Valley, MA$15.00 hourly
Full-time
- Promoted
CLINICAL SPECIALIST
OrganOxMA, United StatesFull-time
- Promoted
CLINICAL NURSE SPECIALIST
Baystate HealthMA, United StatesFull-time
- Promoted
Registered Nurse (RN) - Clinical Support Specialist - $15+ per hour
Tenet MassachusettsWorcester, MA, United States$15.00 hourly
Full-time
- Promoted
CLINICAL TRIAL MANAGER, CLINICAL OPERATIONS
RandstadMA, United StatesFull-time
- Promoted
EMBOLIC CLINICAL SPECIALIST
SirtexMA, United States$30,000.00–$50,000.00 yearly
Full-time
Widex Clinical Education Specialist, Northeast
WS Audiology AmericasMassachusetts, Massachusetts, .USFull-time
- Promoted
CLINICAL : LPN CLINICAL SUPERVISOR
ModivcareMA, United States$33.00–$35.00 hourly
Full-time
- Promoted
Clinical Diabetes Specialist - Western Massachusetts
Sequel Med TechWorcester, MA, USFull-time
Clinical Specialist - Haemonetics Interventional Cardiology (Boston, MA)
HaemoneticsRemote, MA, USRemote
Full-time
Specialist I, Clinical Applications (Boston)
SysmexMA, US This is the time to let your talent come to life.To maximize your knowledge and use it for the greater good.To work with the best professionals using state-of-the-art technology, and improve lives ...Show moreLast updated: 30+ days ago
- Promoted
SENIOR CLINICAL QA SPECIALIST - GCP AUDITOR
Boston ScientificMA, United States$164,500.00 yearly
Full-time
Clinical Account Specialist - Concord, MA
OrganonUSA - Massachusetts - Massachusetts$84,000.00–$142,500.00 yearly
Full-time
- Promoted
CLINICAL SPECIALIST - ADULT ONCOLOGY
Dana-Farber Cancer InstituteMA, United StatesFull-time
CLINICAL QUALITY COMPLIANCE SPECIALIST
LanceSoftMA, United States9 days ago
Job type
- Full-time
Job descriptionLeads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc. Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively provides strategic and tactical directions in the mitigation. Hosts GCP inspections, and provides strategic direction to relevant functions and Subject Matter Experts (SME). Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management. Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed. Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome. Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections. Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc). Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quality Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development. Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management. Leads cross-functional continual improvements projects that enable a compliant quality systems in the clinical trial delivery quality systems. Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered. Escalates issues of potentially critical non-compliance and / or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance. Develops and monitors relevant metrics and Key Performance / Quality Indicators (KPI / KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs / KQIs, ensuring actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs). Contributes to any relevant quality and compliance governance in including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes BSc in a scientific or allied health / medical field (or equivalent degree). Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality / Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP / GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting / leading regulatory inspections and remediation activities on a global level. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives. Skilled in managing global, cross-functional projects. Fluency in written and spoken English, additional language skills a plus
Objectives / purpose :
- Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
- Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
- Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to client values and strategic priorities.
- Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision
ccountabilities :
Education, behavioral competencies, and skills :