Situation:
During a Vendor Management training program conducted by Halloran, additional issues were brought to the forefront by the participants. The company was in crisis at a critical time with a major global trial starting and alarming turnover within the clinical team.
Solutions:
- Conducted an organizational Gap Analysis which revealed significant issues with leadership, structure, planning, and systems.
- Recommended reorganization to augment staff support and slow turnover.
- Defined roles and responsibilities of all internal teams to clarify authority.
- Described a competency model and methodology for assessing training and development needs of staff.
- Managed overhaul of the company's Clinical Quality System.
- Mentored clinical development operations management to initiate an onboarding process and multiple training programs.
- Provided pivotal study team interim leadership support to a struggling program lead, then mentored a replacement.
- Re-engineered trial communication with vendors and retrained the project team to establish clearer expectations.
Value:
Turnover brought to more manageable level and global trial was completed successfully with minimal out of scope cost overruns.