A large international pharmaceutical company implemented a new centralized TMF program. As a result of the new program, the company lacked the trained resources needed to effectively manage the TMF program. LMK provided training and professional mentorship for the newly formed TMF Lead, TMF Project Manager and TMF Document Associates roles.
For each of the three roles (TMF Lead, TMF Project Manager and TMF Document Associates), LMK followed the enclosed approach (which included a detailed work plan) that allowed the department and each individual to flourish and be successful.
- Gap Analysis: LMK evaluated the goals of the company, objective of the role and compared that to the skill set and the education and experience of the resource. LMK created a Gap Analysis document underscoring the differences, which served as the basis for the customized Work Plan.
- Tailored Training: Utilizing the customized Work Plan, LMK was able to select which training modules were needed (from our suite of TMF training) for each individual resource. Additionally, LMK provided one-on-one eTMF training for each TMF resource.
- Highlight Expertise: each person has individual talents and strengths, which LMK emphasized and utilized to create a stronger team. Talents and strengths range from Excel expertise to specific knowledge about a particular document type.
- One on one time: LMK assigned an experience resource from LMK to each resource at the pharmaceutical company to provide individualized attention, oversight and additional training for their specific role.
- Transition: LMK worked with the pharmaceutical company to create a Transition Plan (i.e. knowledge transfer) to ensure that the resources were set-up for success and the process was sustainable for future resources and departmental growth.
As a result of utilizing existing resources and targeting each individuals strengths, the company was able to save >12% of their overall departmental budget. LMK’s processes and tools were customized for future use to help create a robust, sustainable department adding value to their clinical trials program. The new fully trained group also helped decrease the number of audit and regulatory inspection findings.