Clinical Study Manager - Ivd/Medtech - Remote
By NAMSA At United States
Act with integrity in everything we do.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Come and work for an organization with the:
Clinical Study Manager, Clinical Operations
By Daiichi Sankyo, Inc. At United States
Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).
Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).
Education Qualifications (from An Accredited College Or University)
Associate degree or with a nursing diploma with substantial experience preferred.
4 or More Years relevant experience is required with a BS preferred.
Bachelor's Degree in the Sciences preferred.
Clinical Study Manager- Medical Devices
By Integrated Resources, Inc ( IRI ) At United States
Remote will be considered; however, Minnesota or central time zone will be preferred.
Familiarity with electrophysiology and/or cardiac arrhythmias is a plus.
Previous work history with CERs and EU MDRs
Previous work history in medical device or pharmaceutical research (i.e., no academia or research scientist candidate).
Previous work history in the cardiovascular space.
Minimum is BS + proven work history
Clinical Study Support- Icf
By ICON Strategic Solutions At United States
Co-manages maintenance of the centralized Informed Consent Form mailbox.
Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
MUST CURRENTLY WORK AT A CRO/PHARMA
Reviews and validates quality and accuracy of Informed Consent Form templates.
Supports development of Informed Consent Form templates.
Associate Director Clinical Study Management
By BeiGene At United States
Management experience of CROs, Vendors and Consultants preferred
Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
8+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment
Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators
Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required
Clinical Specialist Jobs
By Planet Pharma At United States
Drive program adoption through ongoing clinician education, optimizing workflow, and delivering tangible results
2-5 years’ experience in the acute care healthcare setting
1-3 years’ medical device experience
Service, supply chain, or clinical experience perferred
MUST BE LOCATED IN CALIFORNIA, DENVER, CHICAGO, NYC, OR BOSTON
Engage hospital staff in customer business reviews, leveraging sustainability reports, savings metrics, and tracking to goals defined by the account
Clinical Study Manager Jobs
By Lexitas Pharma Services At United States
Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented
Manages vendors, including the implementation and coordination of vendor’s Scope of Work (SOW).
Manages study budget and timelines. Identifies, resolves, or escalates issues involving study timelines and deliverables
Relevant experience as a CRA preferred
Study planning and set-up, maintenance, and close-out experience.
Must have a solid understanding of clinical research operations including GCP and regulatory requirements and operational procedures
Freelance Clinical Study Manager (Usa) - Remote - Pharma
By MSI Pharma At United States
Global studies to manage in Oncology (you will be responsible for 1-2 studies across Phase II&III)
(Remote in USA) - Pharma sponsor, Oncology
Responsible for managing the clinical monitoring process and the administration of clinical trials.
Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration.
Oversees adherence to SOPs, Good Clinical Practice and regulations
(you will be responsible for 1-2 studies across Phase II&III)
Clinical Research Associate (Study/Ctms/Regulatory)
By Rangam At United States
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Required Skill 5: Experience with using clinical trial management systems
What years of experience, education, and/or certification is required?
Required Skill 1: Clinical Research Experience – could be in various roles (study coordinator, regulatory, compliance, safety, etc.)
What are the top 5 skills/requirements this person is required have?
Required Skill 3: Good communication
Study Activation Specialist Jobs
By Sarah Cannon At United States
You will market Sarah Cannon services and capabilities to pharmaceutical companies, CROs and within the industry network
Knowledge of pharmaceutical industry, regulatory processes, clinical trials and medical terminology
At least one year of experience in Customer Service in a Client Facing Role
Experience in healthcare or marketing
You will develop relationships with sponsors and (CROs), which provide potential studies
You will maintain a database of potential pharmaceutical and CRO relationships
Clinical Study Project Manager
By Rangam At United States
Minimum of 3-5 years of project management experience in the pharmaceutical industry, with a focus on clinical study management
PMP or similar project management certification is preferred
Collaborate with cross-functional teams, including clinical operations, data management, biostatistics, and quality assurance, to ensure seamless study execution
Familiarity with Veeva or other relevant clinical trial management systems
Veeva or similar study management platform
Study Project Manager - 100% remote
Clinical Study Manager - Global
By SRG At United States
• 5 years of study management experience at a sponsor or CRO required
• Working knowledge and experience with Word, PowerPoint, and Excel
• Budget/finance experience on a project level and demonstrates a full understanding of project financials
• Ensure appropriate escalation of issues to Clinical Operations Management
• Phase 1/Clinical Pharmacology CSM experience
• Renal disease experience preferred
Remote: Clinical Study Manager (233133)
By Black Diamond Networks At United States

Description Our Client is looking for a Clinical Study Manager with 7+ year of experience with some focused in rare disease specifically nephrology. This professional will be responsible for ...

Clinical Study Assistant Jobs
By Kelly Science, Engineering, Technology & Telecom At Irvine, CA, United States
Run reports including training matrix reports, metrics for management reviews
Support management of IRB/IEC renewal compliance.
Work with management group to help achieve department goals.
Requires experience and knowledge working with computer systems (Microsoft office –
Assist in payments/tracking for patient reimbursements. Performs data entry in systems
Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.
Clinical Specialist Jobs
By ImpactBio At Los Angeles Metropolitan Area, United States
Outstanding customer-focused and account management skills.
Become an expert at understanding the Healthcare Partner’s unmet needs related to the management and protection of closed surgical incisions.
Effectively communicate the clinical, ease-of-use and cost-savings benefits of NPseal® compared to traditional dressings and NPWT competitive offerings.
Develop and manage relationships with Key Customer decision-makers including Physicians, Nurses, decision makers, and Operating Room staff.
Manage travel and expenses per approved budget and timelines.
Other responsibilities as necessary to perform position.
Clinical Specialist Jobs
By ImpactBio At Greater Pittsburgh Region, United States
Act as the Clinical Expert in the field focusing on education, pull-through and workflow.
Experience in a sales or customer-facing role in Diagnostics, Life Sciences or the Medical Device Industry is required.
Experience working in a HIPAA and CLIA regulated environment preferred.
Excellent written and verbal communication skills.
Proficiency using a CRM system, Salesforce experience preferred.
Experience working in an environment with defined Service Level Agreements and Key Performance Indicators.
Clinical Specialist Jobs
By Abbott Neuromodulation At Chicago, IL, United States
Excellent organizational, time management and prioritizing skills.
EDUCATION AND EXPERIENCE YOU’LL BRING
Provides technical, clinical and programming assistance, primarily in support of 1-2 Territory Manager(s).
Assist Territory Managers in after hours call support and activities.
Works seamlessly with Territory Manager(s) allowing them increased selling time.
Will begin to conduct PCP work and educational in services, as directed.
Clinical Study Nurse Coordinator
By University of Nebraska Medical Center At , Omaha $66,000 - $99,000 a year
Required Additional Knowledge, Skills and Abilities:
Preferred Additional Knowledge, Skills and Abilities:
If any experience is required, please specify what kind of experience:
If yes, what is the required licensure/certification?
Nursing experience in oncology and/or clinical research.
If yes, what is the preferred licensure/certification?:
Clinical Study Support - Icf
By ICON At , Remote
Bachelor’s Degree in business administration, finance, science or related field or equivalent experience.
Central Services Specialist - ICF Management
Co-manages maintenance of the centralized Informed Consent Form mailbox.
Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.
Experience in negotiating vendor contracts/budgets.
Proven ability to effectively manage change.
Sr Clinical Study Coordinator- Full Time -Cancer,Clinical & Translational Research
By Henry Ford Health At , Detroit
Analyzes protocol specific requirements and implements quality assurance measures to ensure physician, patient, and clinician compliance.
Three (3) years of related experience required.
Organizational, analytical, and problem-solving skills required.
Demonstrated verbal and written skills at professional level required.
CERTIFICATIONS/LICENSURES REQUIRED: SOCRA or ACRP certification required.
education and training, the health system has trained nearly 40% of physicians currently practicing

Are you looking for an exciting opportunity to join a dynamic team of clinical research professionals? We are seeking a Clinical Study Specialist to join our team and help us advance our mission of improving patient care through clinical research. As a Clinical Study Specialist, you will be responsible for managing clinical studies, ensuring compliance with regulatory requirements, and providing support to clinical investigators. If you are passionate about clinical research and have the skills and experience necessary to succeed in this role, we want to hear from you!

Overview A Clinical Study Specialist is a healthcare professional who is responsible for the planning, implementation, and management of clinical studies. They work closely with clinical research teams to ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols. Clinical Study Specialists are responsible for the coordination of all activities related to the study, including the recruitment of participants, data collection, and analysis. Detailed Job Description Clinical Study Specialists are responsible for the planning, implementation, and management of clinical studies. They work closely with clinical research teams to ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols. Clinical Study Specialists are responsible for the coordination of all activities related to the study, including the recruitment of participants, data collection, and analysis. They are also responsible for the preparation of study documents, such as protocols, informed consent forms, and study reports. In addition, Clinical Study Specialists are responsible for the training of research staff, the monitoring of study progress, and the management of study budgets. Job Skills Required
• Knowledge of clinical research regulations and protocols
• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Ability to manage multiple tasks and prioritize effectively
• Proficiency in Microsoft Office Suite
• Knowledge of medical terminology
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research
• Certification in clinical research (e.g. CCRA, CCRP)
Job Knowledge
• Knowledge of clinical research regulations and protocols
• Knowledge of medical terminology
• Knowledge of data collection and analysis methods
• Knowledge of study design and implementation
Job Experience
• At least two years of experience in clinical research
• Experience in the preparation of study documents
• Experience in the training of research staff
• Experience in the monitoring of study progress
• Experience in the management of study budgets
Job Responsibilities
• Plan, implement, and manage clinical studies
• Ensure that all aspects of the study are conducted in accordance with applicable regulations and protocols
• Coordinate all activities related to the study, including the recruitment of participants, data collection, and analysis
• Prepare study documents, such as protocols, informed consent forms, and study reports
• Train research staff
• Monitor study progress
• Manage study budgets