Clinical Project Leader Job Description

Clinical Project Leader Job Description

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Clinical project leader provides assistance to clinical research teams in the development of protocol specific plans that adhere to International Conference for Harmonisation (ICH) Good Clinical Practices (GCP), the NIH Standards of Clinical Research, US and International regulations.

Clinical Project Leader Duties & Responsibilities

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

Sample responsibilities for this position include:

Provides input into the clinical development strategy for assigned programs
Plan and implement resource allocations (both people and financial) to the individual projects and activities of the department in collaboration with the Registry Team Lead
Ensure compliance of clinical trials with national and international regulatory requirements
Prepare and maintain required study and regulatory documentation, , reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets
Executes the project management process and the deliverables linked to this process
Allocates workload to ensure optimal productivity, alignment with the priority projects and optimal usage of RCRA staff
Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements
Conduct QCVs when possible for new CRAs or CRAs with any potential quality or milestone deliver concerns
Develop and manage the trial budget
Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles

Clinical Project Leader Qualifications

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

Licensing or Certifications for Clinical Project Leader

List any licenses or certifications required by the position: CCRA, SOCRA, ACRP, PMP, CCRP, CCRC, M.D

Education for Clinical Project Leader

Typically a job would require a certain level of education.

Employers hiring for the clinical project leader job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Healthcare, Public Health, Allied Health, Radiologic Technology, Respiratory Therapy, Health Administration, Associates, Medical, Education, Science

Skills for Clinical Project Leader

Desired skills for clinical project leader include:

Scientific methodologies and clinical laboratory science
Clinical study development
FDA regulations and ICH/GCP guidelines
Clinical development
ICH/GP and regulatory guidelines and directives
European In Vitro Diagnostic Regulation and specific requirements relating to clinical performance data
Medical device regulations
Ability to plan
Aspects of GCP and the regulatory/ethical framework pertaining to clinical trials
Clinical trial design and development in relevant therapeutic areas

Desired experience for clinical project leader includes:

Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans
Ensures appropriate communications channels are maintained and reporting schedules adhered to
Builds a strong relationship with the Medical Affairs project team, platform team and key stakeholders
Oversight and accountable for project performance to ensure it meets the project expectations as far as timelines, quality and budget
Assists Application Analysts and Systems Analysts with day-to-day support of clinical applications
Participate in the preparation of preclinical texts for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers

Clinical Project Leader Examples

1

Clinical Project Leader Job Description

Job Description Example
Our growing company is looking for a clinical project leader. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical project leader
  • Co-lead and/or work collaboratively with project study teams comprised of internal staff and external vendors
  • Review, interpret, and/or apply research concepts from scientific journals to RAIS clinical studies
  • Ensure that studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable FDA regulations/guidance, and RAIS standard operating procedures
  • Lead, contribute to, or assist with the study design and interpretation of resulting data to support product development, regulatory submissions, and exploratory research
  • Lead, contribute to, or assist with the preparation and publication of scientific results obtained from RAIS’s clinical studies in peer-reviewed scientific journals and present, as appropriate, at scientific meetings
  • Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the CRDM activities and deliverables
  • Review clinical investigation plan, patient documentation and case report forms, presentation of study to potential investigators, submission to local authorities, ethical committees and hospital/clinic administrative services, contractual issues incl
  • Supports physicians during the enrolment and follow up phase of clinical studies
  • Train sites in CRF's completion how to answer to queries correctly and the relevance and their responsibility to provide a timely response to queries
  • Train and trouble shoot for student users (2300 students in 24 programs)
Qualifications for clinical project leader
  • DVM or PhD in pharmacology, toxicology, or related scientific discipline
  • Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors
  • Experience with/knowledge of tobacco research
  • Ability to creatively contribute to key strategies at the department/division/enterprise level
  • Experience with publication and presentation of scientific data and their interpretation
  • Job level and compensation commensurate with experience and education
2

Clinical Project Leader Job Description

Job Description Example
Our growing company is looking for a clinical project leader. 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 project leader
  • On campus expert in the software application
  • Identify and addresses reporting requirements with programs and HSSH leadership
  • Train and collaborates with program faculty and leaders
  • Identify gaps in use/utility and recommends possible solutions and efficiencies
  • Understand all aspects of Clinical Education that are housed in E*value (clinical affiliation agreements, student compliance data, placement and tracking, clinical courses, and learning modules
  • Work to ensure that E*Value is used and embraced across all programs
  • Educate faculty and students on the processes and are supported with trouble shooting and timely response
  • Maintain reporting for strategic decision–making and accreditation reporting
  • Provide consistent faculty and student documentation and compliance for all fieldwork and clinical education
  • Leads vendor selection activities
Qualifications for clinical project leader
  • Experience in pharmaceutical company over 5 years at least
  • Experience of CTD prep/launch and/or MSL in oncology/immunology area
  • Fluent in English, the local language (and third language) if possible
  • BS required, preferably in a health related field, MS or PhD desirable
  • MT (ASCP) or equivalent is desirable
  • Experience in coagulation testing is desirable
3

Clinical Project Leader Job Description

Job Description Example
Our innovative and growing company is looking for a clinical project leader. 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 project leader
  • Participates in the development and management of project budgets
  • May serve as direct line manager Clinical Operations team members, including annual performance evaluations
  • May supervise the work of more junior Clinical Research Associates
  • Direct/lead team that is conducting Phase I-IV clinical trials in a timely, ethical and scientifically responsible fashion
  • Key operational interface with internal and external servies to develop, implement, maintain and improve operational processes for NA CSU clinical study conduct and enrollment
  • Interface with the CSO Project Leaders, CTOMs, CSDs, and Project Heads to understand portfolio and project needs and ensure optimal flow of information relative to study status, challenges, risks, etc
  • Ensures study delivery per CSU commitments
  • Responsible for regular assessment and management of resource needs for his/her group
  • Ensure audit report findings are consolidated & communicated as lessons learned
  • Drives change and implementation of new approaches and standards within his/her group
Qualifications for clinical project leader
  • Experience in a medical device/IVD company is a plus
  • Understanding of clinical studies, study design and study management
  • Masters or Doctorate degree in a life science discipline
  • University degree in medicine (MD) and specialty training clinical pathology is a plus
  • 5- 7 years of relevant clinical practice, clinical research, or R&D, and regulatory work experience preferably in medical device, biotechnology or pharmaceutical industry
  • In depth knowledge of nucleic acid based assay methodologies (PCR, sequencing, microarrays, ), DNA/RNA extraction techniques and principles
4

Clinical Project Leader Job Description

Job Description Example
Our growing company is looking to fill the role of clinical project leader. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical project leader
  • Sets clear direction for the global product development strategy from project initiation to Launch Decision (LD)
  • Ensures the optimal blend of team members so that the team is functional from an expertise and interpersonal perspective
  • Ensures all team members and functions are aligned behind the objectives of the team
  • Presents options to stakeholders to gain input/alignment manage up/present to portfolio committee/executive leadership
  • Works with the project team to set challenging project team goals and ensures that best practices are used to attain these goals
  • Motivates and inspires team to achieve challenging goals
  • Creates a positive team environment that instills trust and ensures clear transparent communications and gets the team behind the overall goal/vision for the project
  • Instills sense of urgency and a strong can-do attitude in team members
  • Challenges the team and organization to ensure that the best possible performance is achieved
  • Provides input to team member performance, including extended teams
Qualifications for clinical project leader
  • Knowledge of clinical sample collection process and pre-analytical phase
  • Knowledge of clinical trials and ability to design, review and interpret data from such
  • Project management and system implementation of software across experience preferred
  • Experience with E*Value, the intricacies of clinical education and multi-module software application beneficial
  • This person must have a firm knowledge of IT solutions and tools, interfaces, and linkages and understand the Banner university system
  • Excellent communicator who can translate learning to individuals and groups
5

Clinical Project Leader Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical project leader. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical project leader
  • Promotes debate from functional experts to ensure effective, clear decision making within the team
  • In collaboration with the VP Field Clinical Affairs, AP & Japan, determine which key products will be investigated Design the study protocol if required
  • Ensure protocol compliance compliance with relevant national regulations, including ICH GCP
  • Leads, motivates and organizes the project team to define and execute cutting-edge project strategy in accordance with DIS goals and budget
  • Responsible for developing project plans and leading small projects to completion
  • Participates in PAS innovation, technology development and product development core teams by sensing and defining key trends and unmet needs in science, technology, medical practice, and health economics
  • Reviews and interprets medical/scientific data and study results, and technical literature
  • Monitors trends in laboratory medicine
  • Interacts with global medical, academic and industry experts to establish strategic direction for innovation, technology and product development projects
  • Provides clinical consultation for HFE studies, HEOR studies, post market surveillance and post market studies
Qualifications for clinical project leader
  • Priority setting and leadership
  • Excellent people and emotional intelligence skills and must have a firm grasp of clinical education processes
  • Skills of influence and the ability to work independently yet know when to bring in other resources is essential
  • Minimum of eight (8) years of relevant Clinical Operations experience including at least three (3) years of experience in clinical trial management
  • Comprehensive knowledge of GCP, ICH and FDA guidelines
  • Masters degree in a science related field with a minimum of 5-7 years’ experience with clinical trials management within the healthcare industry or BSc, with additionally 7-10 years’ experience in monitoring clinical trials

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