Navigating Clinical Trial Leadership Turnover: Halloran’s Five-Step Process  

Clinical Trial Leadership—Directors, Associate Directors, and Senior Clinical Trial Managers – is critical to the success of a clinical trial. But what happens when you lose a person filling one of these key roles? Do not panic – there is an extensive network of clinical trial leaders who could be the most efficient and effective option for you to fill your gap. Enter the Halloran consultant. 

Halloran Consultants offer: 

• Quick integration into your existing team, increasing the likelihood of making an immediate contribution and impact 
• Wide depth and breadth of knowledge and experience 
• Support for company goals and objectives, minimizing disruptions to ongoing efforts by quickly assessing the current state, identifying areas for improvement, and implementing changes to enhance efficiency 

There is no reason to rush to fill a permanent position when a capable consultant can bridge the gap, assist with interviewing, hiring, and preparing the transition for the permanent replacement. 

Five-Step Process for Interim Clinical Trial Leadership  

1. Initial Assessment 

Depending on the situation, the Halloran consultant filling a temporary position will begin with a rapid, high-level, initial assessment of the current state of the program or study and gather as much information as possible.  

Halloran strives to plan for a transition period with the outgoing leader, when possible, and the consultant will work closely with the outgoing leader ahead of their departure. If an overlapping transition period is not possible, the Halloran consultant will meet with the remaining study team members to build smooth transition planning and execution.  

Questions that may be explored during the initial phase include: 

• What are the company’s goals and objectives? 
• At what stage is the program or study? 
• Who are the key team members (internal and external)?  
• Is the team set up for success?  
• What are the past or current pain points, issues, risks, and successes? 
• What critical gaps are there, if any?  
• What are the immediate priorities? 

2. Developing Strong Relationships  

Throughout the project, the Halloran consultant will focus on building effective relationships with internal and external stakeholders. With a sudden transition of a clinical trial team member, teams may feel uncertainty or angst. Halloran consultants are experts at navigating this dynamic and rely heavily on their active listening skills, attention to detail for timely follow up, organization skills, and commitment to success to quickly earn the teams’ trust. Consultants also put members of the team at ease by maintaining open lines of communication and mentoring junior team members. 

3. Deep Dive 

Once the Halloran consultant has the “lay of the land,” they will focus on the program and/or study-specific details. This may include reviewing available timelines, budgets, key study documents, and plans. They will also assess whether any key study documents are missing or not being followed.  

4. Process Improvement  

The Halloran consultant will develop an action plan for immediate priorities and get buy-in from key stakeholders on priority urgency. The Halloran consultant will also keep a list of issues and gaps to address once other immediate priorities are addressed. Acting upon gaps and needs identified during the initial assessment and deep dive process, the Halloran consultant will work on improving processes and procedures. 

5. Outgoing Transition 

Since most consultancy roles are short-term – six months or less – the Halloran consultant will monitor and track key actions, decisions, and issues during their engagement to assist with knowledge transfer when the company finds a permanent solution.  

In summary, clinical trial leaders play a pivotal role in the success of clinical trials. Working with a consultant during a time of transition can help make an immediate, positive impact and keep your team driving towards success. You will need to find an expert accustomed to quick acclimations with an ability to adapt in real time to the needs of a particular client, program, or study. 

When you find yourself with a gap in your clinical trial leadership team, consider Halloran’s consultants as a cost-effective and strategic option to minimize your risk. Ready? Contact us today.