Does Your Clin Ops Team Have The Skills To Do Their Jobs?

“What keeps you up at night?” is a question often posed to executive leaders during quarterly earnings or town hall meetings.  The response generally alludes to motivating employees to achieve the company’s mission and goals.  In short, an underperforming team, and therefore company, is a leader’s worst nightmare.

In a previous post, we mentioned that for clinical operations teams to become more efficient, their systems should be the #1 focus for improvement.  However, that’s not to say that the people using those systems don’t need to have existing basic skills.  Otherwise, they won’t be able to fully exploit the great systems and processes that a company has established.  Here, we divulge what these are.

Skill proficiency should increase with seniority

It’s important to note that a skill’s proficiency should increase as a role gains seniority.  For example, it’s fine for a Clinical Trial Assistant to only know how to enter data into a spreadsheet for simple tracking.  However, a Clinical Trial Manager or Clinical Program Manager should know how to use formulas and pivot tables as these roles are frequently asked to report ad hoc trial metrics to senior management. 

Frequently, junior employees have personal interests in certain technical areas and become experts in them.  However, this shouldn’t be an excuse for clinical trial leaders to solely rely on their direct reports and bypass learning these skills.  After all, the most effective clinical trial leaders know how to both lead and be hands-on and technical.

The most important Clin Ops skills:

• Communication:  Because clinical operations is so collaborative, it’s important for employees to  properly use collaboration tools:
  • Email:  Employees should know how to write business emails, what information to keep within the company, versus what they should share with sites and vendors.  Employees should also know when to use email versus another method.
    • Red flag:  employees who send too many and/or poorly thought-out emails (e.g. no clear intention, whether it’s a request, an FYI, documentation, etc.)
  • Instant Messenger: Employees should know when to use this (quick questions that don’t require documentation of answers).  Employees should also be familiar with the related courtesies (don’t message in addition to email except in case of real emergencies and don’t expect immediate responses)
  • Phone:  Same skills as instant messenger above
  • Presentation (PowerPoint):  Employees should know how to present data/study information/business rationale in a slide deck and how to cogently speak to that information (less important for junior employees and more for senior)
  • Meeting Facilitation:  Similar to the above, employees should know how to decide what info and considerations need to be presented and how to foster discussion and decisions related to the presented material (again, more important for senior employees over junior).
• Organization:  Clinical trials have so many tasks and timelines that it’s essential to be intentional about how one uses their time.
  • Employees should know how to prioritize their daily tasks and track progress to achieve short- and long-term study goals. 
  • Senior employees not only need to track their own goals but also that of their direct reports.  Red flag:  someone who doesn’t keep written to-do lists or notes, and instead tackles tasks haphazardly (e.g. the most recent email in their inbox).
• Technologies: These days, tools used for clinical trial conduct are fully digital.
  • Employees should be familiar with EDC, IXRS, vendor portals, EMR systems, etc. depending on their role.  If they need brand or system-specific training, the company should provide this.
  • Employees should know how to use office software suites such as Google for Business or MS Office, especially email, word processing, spreadsheet, and presentation applications.
    • An employee who knows how to fully exploit the capabilities of each application is more useful and efficient than that who uses them superficially.
      • Someone who knows Outlook’s “find related” feature can quickly locate the most recent email in a thread instead of answering an outdated email, wasting everyone’s time.
      • Someone who knows how to use Excel formulas and conditional formatting can build more sophisticated tracking and reporting tools than someone who doesn’t.
• Clinical Trial Knowledge
  • Employees should be familiar with ICH E6 GCP and the major clinical-trial related FDA regulations.
    • This doesn’t mean they need to know them word for word, but rather, understand the “flavor” enough to account for them when making trial conduct decisions.
  • Employees should know general clinical trial timelines and milestones.
    • IND approval
    • EDC go-live
    • First site activated
    • First subject dosed
    • Database lock
    • Etc.
  • Employees should know general clinical trial design.
    • E.g. arms, visit schedules, randomization, etc.
  • Employees should know the trial design for the phase of trial they work on
    • E.g. Phase 1, 2, 3, 4-6
  • Employees should know general clinical trial processes.
    • Vendor management
    • Site activation
    • Protocol-specific EDC design
    • TMF filing
    • Etc.
  • Employees should know the organization, responsibilities, and communication channels of a highly matrixed study management team.
    • Data Management:  Designs EDC, issues queries, etc.
    • Regulatory: Manages FDA submissions, collects updated 1572s, etc.
    • Clinical Science/Development:  Writes protocol, approves subject eligibility, etc.
    • Vendors, CRO
    • Etc.
  • Employees should also know how all of the above ties together!

So, how does a company get employees with these skills?

• The simplest way is through careful hiring.  To that end, these skill requirements should be baked into job descriptions and interview questions/assignments.
  • Get specific!  Instead of asking “are you familiar with Excel?“, ask “what specific Excel skills do you have?“.
  • Similarly, instead of asking “are you familiar with phase 1 trials?“, ask “what’s the hardest part about managing phase 1 trials?” or “how do you accurately track phase 1 escalation subjects?“.
  • In general, ask for information that only a person highly familiar with the skill would be able to answer and probe until you get (or can’t get) a detailed answer.
• For existing employees ready for the next level, the company should provide training to raise proficiency in each of these areas so that the employee is set up to succeed in meeting goals without disruption.

In a previous post, we mentioned tools, processes, and data as the 3 components other than people that could boost your clin ops team’s productivity.

ClinOps Pro was designed by clinical operations people to simplify clinical trial workflows.  ClinOps Pro is the Clinical Operations Oversight Solution that enables employees to make timely trial conduct decisions using accurate data from the start.  Further, it doesn’t require involved training and allows your team to focus on key tasks that drive the company’s overall success.