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
Study Coordinator Jobs
By Meet At United States
Oversee data collection, management, and entry into study databases, ensuring accuracy and completeness
Strong knowledge of clinical research processes, regulations, and guidelines.
Excellent organizational, communication, and interpersonal skills.
Collaborate with study teams to develop and implement study protocols, ensuring compliance with regulatory guidelines and ethical considerations
Coordinate participant recruitment and enrollment activities, including screening, selection, and informed consent processes
BA/BS degree in a relevant subject
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
Study Support Coordinator I
By Clinical ink At United States
Support the organization with daily tasks including user management, site management, equipment requests, data entry and report generation
Provide support for front-end client activities across multiple clinical research studies
Work closely with clients to ensure all data required for study start-up is collected and maintained
Provide details and information to clients in response to inquiries regarding study support and set-up
Update project-related internal databases and electronic files to ensure accuracy
Assist with special department projects
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
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
Central Study Coordinator Jobs
By Care Access At United States

What You'll Be Working On

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.
Research Study Coordinator Jobs
By University of Washington At Seattle, WA, United States
Demonstrated experience in grant preparation, contract management, and IRB protocol development/adherence;
Strong organizational and time management skills with ability to lead research projects;
A Bachelor's degree in a relevant academic area AND two years of experience as a Research Study Coordinator DESIRED QUALIFICATIONS
Other miscellaneous administrative support. MINIMUM REQUIREMENTS
Experience in the preparation of academic manuscripts, posters, and presentations;
Excellent verbal and written communication skills including the ability to communicate via email effectively and efficiently; the ability to work independently;
Clinical Research Coordinator - Maternal-Child Environmental Health Prospective Cohort Study
By Northwell Health At , New Hyde Park, 11042 $58,540 - $92,650 a year
Bachelor's Degree required, or equivalent combination of education and related experience.
Adheres to Good Clinical Practice, regulatory, and grant agency requirements
Collects, labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements
1-3 years of relevant experience, required.
Completes the activities assigned to the Clinical Research Coordinator by local research team and ECHO program leadership
Maintains comprehensive study documents/records as requested by ECHO program core elements, regulatory agencies, the NIH, and local study leadership
Program Coordinator (Sports & Bible Study Missionary)
By Catholic Sports At , $25,000 - $69,000 a year
Management and leadership development, including opportunities to advance in Catholic Sports
Missionaries will also be offered benefits, not limited to, but such as:
15% managing volunteer league managers and visiting their leagues, or running leagues in the absence of volunteers
Interpersonal skills are critical for this role: Being invitational and outgoing towards participants, especially the newcomers
Computer/technical skills (Google products, Microsoft Office, Windows and social media marketing
25% leading the Bible study regional effort, including leading their own Bible studies & one-on-one outreach/discipleship
Study Coordinator Ii Jobs
By Cayuse Native Hawaiian Veterans, LLC At , Honolulu $30 - $35 an hour
Minimum 6 years or successful execution of over 30 clinical trial studies or collaborative biomedical laboratory study experience (Study Coordinator II)
Preferred experience in managing investigator-initiated, industry-sponsored, or military studies.
Ability to analyze data and summarize findings for incorporation into reports.
The Contractor shall match sponsored studies with appropriate Principal Investigator.
The Contractor shall assure that logs and collected data from patients enrolled in the study remain confidential.
Must have a Bachelors of Science in biomedical science field or nursing
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?:

Are you looking for an exciting opportunity to be part of a dynamic clinical research team? We are seeking a Clinical Study Coordinator to join our team and help us make a difference in the lives of patients. As a Clinical Study Coordinator, you will be responsible for managing clinical studies from start to finish, ensuring that all study protocols are followed and that data is collected and reported accurately. If you are a detail-oriented individual with excellent organizational skills, this could be the perfect job for you!

Overview Clinical Study Coordinators are responsible for managing the day-to-day operations of clinical research studies. They are responsible for ensuring that all study protocols are followed, that data is collected accurately, and that the study is conducted in compliance with all applicable regulations. Detailed Job Description Clinical Study Coordinators are responsible for the overall management of clinical research studies. This includes developing and implementing study protocols, recruiting and enrolling study participants, collecting and managing study data, and ensuring that all study activities are conducted in compliance with applicable regulations. Clinical Study Coordinators also provide support to the study team, including physicians, nurses, and other healthcare professionals. Job Skills Required
• Strong organizational and communication skills
• Knowledge of clinical research protocols and regulations
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and other computer applications
• Ability to manage multiple tasks and prioritize work
• Attention to detail
Job Qualifications
• Bachelor’s degree in a related field
• Previous experience in clinical research or healthcare
• Certification in clinical research (e.g., CCRC, CCRP, etc.)
Job Knowledge
• Knowledge of clinical research protocols and regulations
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of medical terminology
• Knowledge of data management systems
Job Experience
• Previous experience in clinical research or healthcare
• Experience in data collection and management
• Experience in recruiting and enrolling study participants
Job Responsibilities
• Develop and implement study protocols
• Recruit and enroll study participants
• Collect and manage study data
• Ensure compliance with applicable regulations
• Provide support to the study team
• Monitor study progress and report any issues
• Prepare study reports and presentations