Clinical Study Manager Job Description

Clinical Study Manager Job Description

4.6
166 votes for Clinical Study Manager
Clinical study manager provides input on study documents like study protocol, CRFs, Informed Consent, clinical study monitoring plan, clinical study report.

Clinical Study Manager Duties & Responsibilities

To write an effective clinical study manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical study manager job description templates that you can modify and use.

Sample responsibilities for this position include:

Consistently review all monitoring visit reports for the assigned trials to identify trends
Responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with Good Clinical Practices, and all National and Local Regulations
Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research
May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates
Monitor status of site budget and contract negotiations the collection and review of essential documents
Drive study site communication and engagement
Routinely monitor progress against program goals
Implement processes to ensure deliverables are met within timelines and teams are working according to established plans
Manage vendors across assigned MAF SM sponsored studies
Communicate to team members in a concise and professional manner

Clinical Study Manager Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Study Manager

List any licenses or certifications required by the position: PMP, ACRP, GCP, IVD, CE, GDPR, IVDR

Education for Clinical Study Manager

Typically a job would require a certain level of education.

Employers hiring for the clinical study manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Life Sciences, Health, Education, Nursing, Project Management, Medical, Healthcare, Management, Technical

Skills for Clinical Study Manager

Desired skills for clinical study manager include:

Project management tools
Sites
Clinical study design
Protocol and clinical drug development processes
International standards
Monitoring
Study planning and management
Study protocol to answer standard operational questions from CRAs
Internal Country/Cluster personnel
Local internal personnel

Desired experience for clinical study manager includes:

Expert knowledge of relevant regulations ICH/Good Clinical Practices, FDA guidelines
Life Sciences degree or equivalent in education English written and spoken
2+ years in a project management role, strong project management skills
Experience in a monitor role
Proven track record in clinical operations including study set-up, protocol management, regulatory/ethics applications, study logistics
Effective site management and organizational skills / ability to meet key study milestones

Clinical Study Manager Examples

1

Clinical Study Manager Job Description

Job Description Example
Our growing company is hiring for a clinical study manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical study manager
  • Facilitate short and long term planning for assigned programs
  • Assess and appropriately delegate tasks within assigned programs to team members
  • Provides tactical and strategic clinical operations oversight and direction ensuring collaboration across multiple phase I project/programs to translate our science into reality through high quality clinical trial conduct
  • Responsible for the overall operational execution of clinical studies on clinical projects/programs
  • Matrix manage assigned cross-functional study team members to ensure compliance and execution of deliverables within approved budget and timelines
  • Manage the implementation, on-time execution and conduct of clinical studies
  • Monitor the status of site budget and contract negotiations the collection and review of essential documents
  • Develop and manage Study Management plan and all associated documents
  • Plan, facilitate and lead SET internal meetings act as the CSL lead for vendor meetings
  • Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
Qualifications for clinical study manager
  • Previous experience in Cardiology an advantage, but not a must
  • Good understanding of clinical research and working knowledge of ICH-GCP
  • Work experience with global/regional teams
  • Strategic & tactical thinking skills
  • Client-focused action-oriented approach to work
  • Highly confident to deal with client and internal resources at all levels
2

Clinical Study Manager Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical study manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical study manager
  • In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster
  • Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical
  • Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
  • Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
  • Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
  • Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies, post CRA Manager review (may act as primary reviewer in countries where CRA Managers do not exist)
  • Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate
  • Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
  • Leads product development or marketing study programs in conjunction with and under direction of Clinical Affairs management, working closely with all departments and key stakeholders
  • Manages clinical studies that involve sponsor-initiated studies OUS
Qualifications for clinical study manager
  • Able to work independently and manage assignments from a distance
  • Strong understanding of cultural differences
  • Proven client-facing relevant experience in healthcare, clinical research, project management or contract research organization
  • Prior Project Management experience required, Critical Path Management preferable
  • End to End study start-up experience & expertise preferred
  • 3+ years experience in clinical research management
3

Clinical Study Manager Job Description

Job Description Example
Our company is growing rapidly and is looking for a clinical study manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical study manager
  • Ability and confidence to run study status reviews and other key team meetings
  • Communicates program’s study status to management and cross-functional teams
  • Coordinates the management any CROs selected by company to perform site management of a clinical study
  • Ability to direct personnel to achieve desired results related to clinical study execution without direct personnel management required
  • Devises efficient, effective clinical trial execution strategies
  • Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for clinical trials
  • Generation or review of study documents relevant for regulatory submission
  • Align activities with team members
  • Create and report clinical study updates to management on a regular basis
  • Accountable for the implementation and embedding of the Clinical Study Support flexible resource model and eTMF support model supported by our FSP
Qualifications for clinical study manager
  • Minimum 5-6 years of experience in clinical research (GCP education – LIF/LMI or equal) incl
  • Bachelor’s Degree or equivalent is required, typically in nursing, medical or scientific field
  • 7+ years of pharmaceutical or biotech-related/clinical research related experience is required
  • Considered a subject matter expert and Competent in application of standard business procedures (SOPs, ICH-GCP, Global Regulations, Ethics and Compliance)
  • Experience in successful study initiation through study completion/primary data analysis and/or in early phases of clinical development (Phase I-3)
  • Must have strong knowledge of ICH/GCP guidelines
4

Clinical Study Manager Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical study manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical study manager
  • Accountable for implementing the new eTMF support model
  • Accountable for the identification of appropriate capable resources to support the workload and personal development opportunities for eTMF support model and for global Clinical Study Support staff to support R&D strategies within PCPS
  • Drive and ensure an effective model is in place to support the implementation of eTMF across Pharma R&D
  • Responsible for ensuring staff work to the highest quality that enables study teams to be ‘Inspection ready’ at all times
  • May collaborate with CTS team to plan and coordinate IMP and non-IMP supplies
  • May report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
  • Co-monitor as needed
  • Communicate study results through annual reports, investigator meetings, and global clinical discussions
  • Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
  • Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate
Qualifications for clinical study manager
  • 3-5 years of relevant clinical study management experience
  • Current in-depth knowledge of clinical study budget and contract development
  • Program Management related to clinical studies
  • Medical device, pharmaceutical industry, or other regulated environment experience is required, with medical device clinical study experience high preferred
  • Proficiency in Microsoft Office and Visio is required
  • Excellent communication skills with the ability to convey clinical, regulatory and business information clearly and effectively through informal and formal documents, reports, and presentations to management
5

Clinical Study Manager Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical study manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical study manager
  • Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites
  • Oversees local vendor selection and performance as needed
  • Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
  • Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets
  • Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
  • Leads/chairs local study team meetings or supports Sr
  • Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
  • Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
  • Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
  • Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Qualifications for clinical study manager
  • Proven ability to manage conflict and work under tight deadlines
  • Be a member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Medical Affairs, Regulatory Affairs and Biometrics in the study overall design, validation and planning
  • Bachelor’s Degree in nursing, scientific, or equivalent required
  • Scientific background in biological sciences
  • Working knowledge of various tools used in clinical trials including electronic data capture, electronic clinical outcomes
  • Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred

Related Job Descriptions

Resume Builder

Create a Resume in Minutes with Professional Resume Templates