Clinical Trial Learning and Development Analyst

IQVIA•Parsippany, NJ

15d

About The Position

Job Summary: CTL&D Analyst provides support to CTL&D for study-specific training planning within various therapeutic area(s). Service/deliverables include support to deliver on study-specific training related processes, including, but not limited to development/ documentation of the study-specific training plan for each protocol assigned. Further, services may include project related work, as assigned by CTL&D Leads and/or Leadership, and will ensure quality and that work is compliant with company Standard Operating Procedures (SOPs). Partners with CTL&D colleagues, Learning Systems Solutions (LSS) organization, and designated study team trial leaders to ensure training plan is documented and implemented in appropriate systems with supporting documentation. Deliverables: Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. Develop and document the study-specific training plan for assigned studies. Conduct and/or supports needs assessments to determine the full scope of study level training needs while considering potential challenge areas to focus on based on available data and in-depth discussions with the Global Study Team. Support end-to-end development of study specific training strategy from concept to the design, development, and maintenance of effective training materials in accordance with Standard Operating Procedures and Good Clinical Practice while also considering adult learning principles. Manages content of training repository with appropriate mechanisms in place to support version control and compliance. Manage project timelines between Study Teams and/or Vendors. May develop training modules using approved authoring tools (e.g., SCORM, MP4, etc.). Contribute to lessons learned and overall continuous improvement. Collaborate with subject matter experts to facilitate the creation of training materials. Supports oversight of operations process, tools and reporting and ensures necessary training/ support established. Proactively identify issues to study team contacts and collaboratively develop solutions. Responsible for championing the study-specific training process across the organization. Contributes to onboarding new CTL&D colleagues, including mentoring others on study-specific training process and requirements. May contribute as a representative of functional area in process initiatives, as required. Complies with relevant training requirements.

Requirements

Bachelor’s degree required
2+ years of clinical trial operation experience.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
Strong IT skills in appropriate software and company systems.
Proficient in speaking and writing in English.

Nice To Haves

Degree in a health or science related field preferred
Experience within developing study specific training plans highly preferred.
Willingness to travel with occasional overnight stay.

Responsibilities

Develop and document the study-specific training plan for assigned studies.
Conduct and/or supports needs assessments to determine the full scope of study level training needs while considering potential challenge areas to focus on based on available data and in-depth discussions with the Global Study Team.
Support end-to-end development of study specific training strategy from concept to the design, development, and maintenance of effective training materials in accordance with Standard Operating Procedures and Good Clinical Practice while also considering adult learning principles.
Manages content of training repository with appropriate mechanisms in place to support version control and compliance.
Manage project timelines between Study Teams and/or Vendors.
May develop training modules using approved authoring tools (e.g., SCORM, MP4, etc.).
Contribute to lessons learned and overall continuous improvement.
Collaborate with subject matter experts to facilitate the creation of training materials.
Supports oversight of operations process, tools and reporting and ensures necessary training/ support established.
Proactively identify issues to study team contacts and collaboratively develop solutions.
Responsible for championing the study-specific training process across the organization.
Contributes to onboarding new CTL&D colleagues, including mentoring others on study-specific training process and requirements.
May contribute as a representative of functional area in process initiatives, as required.
Complies with relevant training requirements.