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OGL 481 Pro-Seminar I: PCA-Choosing An Organization Worksheet

Carl was hired as the new Senior Manager of a clinical research department within a large biotechnology company. The department was previously disorganized with product teams working independently without standardized processes. Carl implemented new standardized operating procedures and a quality control tool to streamline workflows. However, 9 of the 11 product managers strongly resisted Carl's changes and authority as their new leader. This created a difficult situation for Carl to manage as the product managers rejected and ignored his leadership.

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0% found this document useful (0 votes)
80 views

OGL 481 Pro-Seminar I: PCA-Choosing An Organization Worksheet

Carl was hired as the new Senior Manager of a clinical research department within a large biotechnology company. The department was previously disorganized with product teams working independently without standardized processes. Carl implemented new standardized operating procedures and a quality control tool to streamline workflows. However, 9 of the 11 product managers strongly resisted Carl's changes and authority as their new leader. This created a difficult situation for Carl to manage as the product managers rejected and ignored his leadership.

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© © All Rights Reserved
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OGL 481 Pro-Seminar I:

PCA-Choosing an Organization Worksheet

Worksheet Objectives:

1. Identify an organization and situation you want to study over the remainder of the course.

2. Describe the organization and the situation

1) Name and describe your organization.

CONFIDENTIAL: To protect the anonymity of the organization I will refer to the


company as BioPharma, which is one of the world’s leading biotechnology companies. A values-
based company, deeply rooted in science with a core strategy and belief that innovative, highly
differentiated medicines that provide large clinical benefits in addressing serious diseases are
medicines that will not only help patients but also will help reduce the social and economic
burden of disease in society today. The organization is amazing and does so much philanthropic
work that I am proud to have worked for the company. Unfortunately, the department I worked in
was not run in a way consistent with the values and reputation of BioPharma. It is why I try to
honor the company by using a pseudonym.

2) Describe your role in the organization (it can be an internal or external role).

I worked for a Contract Research Organization (CRO) remotely from my home on the
East Coast. I was contracted as a “fully embedded” employee, meaning I was essentially a fully
functioning member of BioPharma, which was located on the West Coast. As a senior-level
associate, I collaborated with product managers (PMs) to satisfy client contractual,
organizational, and relationship needs and expectations by contributing to developing,
maintaining, and approving project plans and activities, departmental process clarification,
process improvement, issue resolution, adherence to the contractual agreement (time, quality,
scope, and cost deliverables) and participated in new clinical trial (CMTS) setup.

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3) Describe the situation, including information you think the will help the reader
understand the most important elements of the situation. (This will require
selectivity: part of the art of case writing is separating the essential facts from the
mass of information that might be included).

CONFIDENTIAL: In my department, all of our activities were data-driven. We were


collecting scientific clinical research data, to prove that our investigational new drugs (IND)
were therapeutically significant, efficacious, and safe, so the FDA would approve our INDs for
multiple and new indications. My supervisor, Carl, had worked in Clinical Research for over 10
years, previously he worked in Data Management and had a very strong understanding and
experience working with data. Carl knew every role in our department, inside and out because he
worked his way from junior level associate up to Senior Manager over the 10 years he worked in
our department.
At the time he took over leadership of the department, the Product teams were working as
silos. The department was chaotic, no one could fill in or cover for someone when they were on
vacation, because of how vastly different each Product Manager (PM) was managing their
Product's projects. Since Carl had such extensive experience in all of the roles within our
department and he was detailed, analytical and logical and a skilled trainer, he immediately went
to work streamlining our processes (SOPs) and creating a global Quality Control tool (I assisted
him in this effort). He was able to explain every step of the process, why the step was important,
and how each step impacted ( or populated into) other steps, systems, and processes. He worked
with IT to rebuild our Clinical Trial Management System (CTMS) so that it mapped out every
step that needed to happen, including populating “due date reminders” into the system to ensure
every project stayed on schedule and that nothing was inadvertently missed. The changes he
made were helpful, and smart, and aligned our department with the industry standards.
Nine of the eleven PMs in my department were outraged, they felt that he had no right to
change things and expect them to do their job differently from how they always had done it.
They were argumentative and belligerent towards every change he made for the department. He
could not do anything right in their eyes. No matter what he said to them, they just were not
willing to follow his instructions or leadership. They rejected and ignored his authority and
positional power. I defended him several times in meetings because the changes he was
implementing were long overdue and desperately needed, but I was the newest addition to the
team and had no power, authority, or influence within the team.

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