Clinical Lead Job Description

Clinical Lead Job Description

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Clinical lead provides clinical care up to the scope of a registered nurse in the State of Maryland including performing nursing assessments, screening of risk factors, ordering tests, administering medications and immunizations per standard of practice and standing orders.

Clinical Lead Duties & Responsibilities

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

Sample responsibilities for this position include:

Oversee the progress of the clinical trial and ensure that the trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), GCP and applicable regulatory requirement
Produce monitoring reports within (draft and final) outlined SOP timelines
Acts as primary liaison between CRO CRAs, Field Based CRAs and the PM
Leads in developing trust through transparency in communication and individual actions
Alignment of cross functional team regarding program execution
Manages the activities of standards management vendors
Develops and implements clinical supplies strategy with Clinical and Medical project managers and contract provider
Teach and/or assist in the teaching and administration of courses
Understand and manage the study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with Quintiles
Be main contact for Quintiles (or other CRO) for a specific program/study

Clinical Lead Qualifications

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

Licensing or Certifications for Clinical Lead

List any licenses or certifications required by the position: BLS, CCDM, PMP, ACLS, CPR, BCLS, ASCP, CNOR, AAALAC, MA

Education for Clinical Lead

Typically a job would require a certain level of education.

Employers hiring for the clinical lead 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, Science, Medical, Healthcare, Life Science, Health Care, Allied Health, Health, Life Sciences

Skills for Clinical Lead

Desired skills for clinical lead include:

Project management practices and terminology
Scope of the registered nurse
Procedures and techniques involved in administering routine and special treatments to patients
Professional theory
Practice and procedure
Appropriate application of the nursing process
Licensed practical nurse and nursing care assistant
Current coding
Good Clinical Practice guidelines
OSHA and CLIA regulations and ProHealth policies

Desired experience for clinical lead includes:

1-2 domestic trips annually
1-2 international trips annually (Investigator meeting dependent)
Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships
Bachelor's or Masters degree in scientific or related field is required
Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results
Acts as Standards area project manager for selected standards projects

Clinical Lead Examples

1

Clinical Lead Job Description

Job Description Example
Our company is growing rapidly and is hiring for a clinical lead. 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 lead
  • Provides clinical operations guidance to Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs) as needed
  • Promotes operational efficiency, teamwork and high morale amongst CTAs and CRAs
  • Communicates monitoring and site management updates or issues to team
  • Proactively prevents and identifies issues related to the clinical portion of the study, including study processes, monitoring or site issues
  • Sets up and maintains Clinical Monitoring tracking tools and develops study tools and templates for monitors and site personnel
  • Develops the study Clinical Monitoring Plan and ensures CRA compliance
  • Participates in site start-up activities, including site selection and regulatory document collection, review, approval and tracking, and the development of informed consent forms, template source documents, study manual, regulatory binder and other study related documents
  • Works with Clinical Program Management to identify and manage appropriate CROs and study suppliers
  • Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports)
  • Works closely with line and department management for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary
Qualifications for clinical lead
  • Leads the assessment of updates and/or suggested enhancements to the standards library, standards knowledgebase/governance portal, OpenCDISC and other applications
  • Minimum 8-10 years in Data Standards or Data Management or Programming or Statistics
  • Up to 1 international trip
  • 7+ years of demonstrated leadership and experience in Device/Drug Development Prefer experience in Glaucoma
  • Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO, with 4 of 8 years in a Clinical Project Manager role or similar position
  • Presents and participates in Investigator Meetings, other study trainings and meetings as required
2

Clinical Lead Job Description

Job Description Example
Our company is growing rapidly and is looking for a clinical lead. 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 lead
  • Assist with the monitoring of difficult sites or studies that may be too challenging for a less experienced CRA
  • Ensuring appropriate subject recruitment plans are in place
  • Applies extensive technical expertise in a disease/diagnostic area or product/platform, and is recognized internally as technical or subject matter expert
  • Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims
  • Manages multiple long-term projects without supervision
  • Formulates short term planning and makes decisions for individual deliverables and contributes to long-term planning for business/function
  • Creates complex, coherent, professional documentation and correspondence
  • Develops components of a local or functional budget
  • Independently develops training material requiring little or no review by others
  • Anticipates potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Qualifications for clinical lead
  • Must be able to independently present complex program and/or study information to internal and external stakeholders
  • Proven ability to manage and communicate effectively with research vendors including negotiating conracts, reviewing requests for proposal, analyzing scopes of work, and responding to inquiries and complaints
  • Organization is required
  • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
  • Data review and cleaning of ongoing studies
  • Identifies process improvement opportunities in own area of responsibility and in related areas
3

Clinical Lead Job Description

Job Description Example
Our company is looking for a clinical lead. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical lead
  • Under the general supervision of the unit’s Director, Manager or designee, the Clinical Coordinator assumes responsibility for direction and coordination of all functions in the unit on his/her designated shifts
  • Ensures leadership and clear/concise communication both intra- and interdepartmental
  • Organizes kick-off meeting with monitoring team (MTs)
  • Organizes training of monitoring teams (study procedures, study devices, monitoring plan, etc)
  • Organizes investigators meetings (local, cluster or regional) as applicable
  • Provides support to MTs (protocol, monitoring plan, CRF, tools )
  • Arranges the preparation of protocols, written subject information, CTA and other essential documents for studies initiated locally
  • Prepares/supervises the preparation of local study AED within/across the country/cluster/ regions, and ensures optimization of costs
  • Prepares basic documents for initial submission process and to answer clarifications/requests from ECs/IRBs/HA
  • Ensures the implementation of IT systems in the countries (IVRS, eCRF,ePortal)
Qualifications for clinical lead
  • Bachelor degree required, with preferred education/experience focus in the life sciences, clinical, laboratory or other relevant technical areas
  • Minimum 3 years’ experience in Medical Affairs, or as a functional Core Team member, with experience in managing multiple complex or multi-stage projects preferred
  • Experience with molecular platforms is preferred
  • Proven success as a subject matter expert in platform area of focus, or on functional teams across businesses/regions
  • Proficiency with MS Project and Visio is preferred
  • Manages financial aspects of assigned clinical program or study(ies) and provides to Development Team Lead
4

Clinical Lead Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical lead. 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 lead
  • Ensures adequate provisioning of IMP (Investigational Medicinal Product), and non-IMP, devices and materials in the country/cluster/ regions
  • Participates in the revision/preparation of study progress tools
  • Defines with the MT planning of sites and patients breakdown
  • Ensures continuity of care of patients through contacts with mental health providers, EAP and health care practitioners when appropriate
  • Assist the department Clinical Director/Manager in developing and implementing clinical workflows and strategies for clinical programs, inclusive of workflows with the physical health partners
  • Monitors clinical audits/ reports to ensure adherence to clinical workflows
  • Educate, orient and train new clinicians
  • Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required
  • Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters
  • Improve working relationship with vendors
Qualifications for clinical lead
  • Responsible and accountable for the clinical operations budget for the project
  • Responsible and accountable for managing the clinical operations timelines as agreed with the client
  • Participates in internal project review meetings
  • Coordinates and oversees IRB/IEC/regulatory document collection, processing and maintenance activities
  • Responsible and accountable for study specific revision and maintenance of Monitoring Plan, Resource Management Plan for Clinical Operations, and Training Plan for Clinical Operations
  • Responsible for the clinical management of approved sub-CROs
5

Clinical Lead Job Description

Job Description Example
Our company is hiring for a clinical lead. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical lead
  • Responsible for broad corporate stakeholder management and ongoing issue resolution related to the proposals, pilot and implementation of the new processes, roles and additional changes resulting from the “Initiative”
  • Responsible for ensuring the connectivity of the 5 main work streams comprehensiveness, prevention of gaps and redundancies
  • Oversees implementation and tracks/reports metrics
  • Monitor project scope, schedule and costs to ensure all remain on track per contract
  • Aid in development and maintenance of key project performance indicators for client specified metrics
  • Collaborate with finance to initiate monthly invoicing as assigned
  • Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOP and are working within the assigned allocation
  • Provide performance feedback of team members to respective line managers
  • Present at external and/or internal meetings as required
  • Define and manage project human resource needs and establish succession plans for key resources
Qualifications for clinical lead
  • Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Site monitoring and study site management requirements
  • Applicable regional regulatory requirements
  • Trip report review, risk planning, study plan development, resource planning and data management oversight
  • In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered
  • Demonstrated good planning and organization skills

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