Clinical Leader Job Description
Clinical Leader Duties & Responsibilities
To write an effective clinical leader job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical leader job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Leader Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Leader
List any licenses or certifications required by the position: CPR, BLS, BCLS, AHA, PALS, ACLS, MD, CDN, CNN, CRRN
Education for Clinical Leader
Typically a job would require a certain level of education.
Employers hiring for the clinical leader job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Education, Life Science, Healthcare, Science, Health, Health Sciences, Medical, Communication, Graduate
Skills for Clinical Leader
Desired skills for clinical leader include:
Desired experience for clinical leader includes:
Clinical Leader Examples
Clinical Leader Job Description
- Perform data identification, collection, mining and analysis
- Identify new tools and techniques to continue to improve and refine Solution Optimization Service methodologies
- Develop & deliver presentations to influence outcomes, in line with overall company and division objectives, at all customer organizational levels (from front line managers up to and including executive leadership)
- Monitor, track and routinely report on engagement satisfaction, customer satisfaction and financial performance
- Serves as a member of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
- Responsible for overall execution of non-regulated small clinical projects
- May assist in a large clinical regulated study managed by a CPM or Senior CPM
- Solves problems arising during clinical study execution with support from CPM, and will seek guidance for more complex problems, as needed
- Manage all activities of assigned clinical studies within the Clinical R&D Operations group
- May serve as the primary contact for clinical sites
- Minimum of 10 years' experience in identifying, designing, recommending, and implementing efficient, innovative business solutions to clients' complex drug benefits challenges
- Renowned expertise and industry reputation in the pharmacy field
- Must have a minimum of a BA/BS degree in medical and/or nursing, healthcare technology, related science or engineering
- Lean Agent Certification is preferred
- Must have 5+ years of experience in Clinical & Laboratory environments
- Experience in sales, capital sales or account ownership a plus
Clinical Leader Job Description
- Interface and collaborate with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
- Provide quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
- Overall execution of small-medium regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to, study planning, initiation, budget tracking, tracking and supporting subject recruitment, quality of deliverables, site support and study closure
- Manage scientists responsible for disease area biomarker strategies for atezolizumab (anti-PDL1)
- Responsible for biomarker strategies in clinical trials
- Identification of mechanism based combinations
- Translation of cutting-edge research into useful diagnostic tools
- Evaluation of cutting edge technologies as they pertain to biomarker discovery or development
- Manage/Direct workload within workgroup from initiation through closeout, ensuring that departmental goals and metrics are being met
- Troubleshoot and execute problem solving with minimal managerial supervision
- Demonstrated ability to develop and sustain strong customer relationships
- Demonstrated ability to understand, interpret and communicate complex subject matter
- Demonstrated strong technical product knowledge of laboratory instrumentation, informatics and automation solutions
- Strong Microsoft Office skills (EXCEL, PowerPoint, Word, Visio) are required, working knowledge of statistical software (Minitab preferred)
- Business-level/fluent English (oral and written)
- Approximately 4 years technical, operational and managerial experience in planning, executing, reporting and publishing early phase clinical studies in a Sponsor/Pharmaceutical company
Clinical Leader Job Description
- Identify and manage payment risks and issues, escalating compliance and financial challenges as appropriate
- Lead innovations through lessons learned and best practice sessions
- Provide performance feedback for team members on their individual performance reviews and ensure all direct reports are appropriately trained
- Ensure departmental compliance with applicable Corporate and Divisional Policies and procedures
- Identify opportunities to enhance systems by being the voice of the team for MIDAS, SAP, and contracting systems
- Manages overall process improvements, change management, and training for functional area
- Effectively collaborates with internal and external resources
- Will have supervisory responsibility for direct reports
- Leads the cross-functional Study Management Team (SMT)
- Identifies key milestones and tracks critical study activities, issues and strategic priorities
- Experienced in early phase clinical studies including dose escalation and First in Human
- Good knowledge and experience of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
- Oncology or Haematology early clinical development
- Phase III study experience (helpful as additional experience but not your main experience)
- Thorough knowledge of GCP, ICH Guidelines, local country requirements, and regulatory processes as they apply to the clinical development process
- 7 years of clinical trial experience within pharmaceutical, biotechnology or CRO and/or healthcare setting (ie., managing the logistics of clinical trial conduct and developing/executing project plans for clinical development projects
Clinical Leader Job Description
- Identify opportunities to use the results of development projects in sales situations or marketing material
- Support clinical optimization, evaluation of new software, options, and systems prior to release
- Support Clinical aspects of Product Documentation pre and post launch
- Support and participate in development of high quality clinical Marketing Images
- Support clinical aspects of Marketing activities to promote GEHC PoC Ultrasound products throughout all phases of the product lifecycle
- Develop working knowledge of diagnostic and monitoring tools used by PoC physicians in their practice
- Lead, either autonomously or collaboratively project deliverables for each major component of a transversal project, as assigned
- Major challenges will include potential delays from resource constraints in contributing cross functional departments, technology-related parts of a project or from readiness of target populations to implement IR, PAI preparation activities or a business process change
- For process improvement and development inspection readiness and PAI preparation collaboration and co-leadership, the challenge will be to creatively find/negotiate win-win solutions to meet all stakeholder requirements while maintaining compliance with all necessary standards, regulations, quality audit recommendations and established timelines
- For the integration of process in implementation plans, it will be challenging to bring the Business Owner process definition to a timely conclusion in order to meet the deliverable deadlines for roll-out
- Demonstrates core understanding of medical terminology and clinical trial act
- Degree in Medicine (MD) is required
- Bachelor’s Degree/Engineer in related fields
- CRA certificate
- 3-5 years of experience as a clinical research leader at a medical devices/ pharmaceuticals company
- Excellent English (writing, reading and speaking) skills
Clinical Leader Job Description
- Responsible for conducting the root cause analysis to resolve the product vs
- Ensure that all new products are clinically relevant and all clinical needs are translated into technical and performance specifications
- Lead protocol development and writing, draft publications, posters
- Oversee project planning (development of project timelines, deliverables and budget)
- Lead or oversee the preparation for Investigator Meetings
- Ensure study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local Regulations
- Work with the wider clinical operations team to identify, collect, track and improve study related metrics and KPIs
- Collaborate with other clinical operations functional groups (UT and / or CRO) to ensure proper management of clinical study sites, ensuring adherence to all agreed milestones and deliverables
- Assist in managing study budget, timelines, quality and performance expectations
- Build and maintain long-term professional relationships with clinical investigators
- Ability to lead initiatives to facilitate operational efficiency
- Profound experience in clinical supply chain management incl
- Bachelor’s degree and 8+ years of clinical research experience
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)Clinical Trial Administration
- Oversees cross-functional activities and ensures delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs
- Provides guidance, approves and implements study plans including