Life Science Project / Program Management
Specializing in pharmaceutical SaaS Based implementations, system migrations and eClinical strategies
Clinical Systems Project and Program Management
Michael Rosenberg has managed multiple programs and projects at various Pharmaceutical Organizations.
Michael headed up a phase 0 to replace an old monolithic CTMS (Clinical Trial Management System) and led the initiative to not only replace the current CTMS but to look at the systems, informational flow, and functions needed to successfully initiate, execute, and properly close out studies under an eClinical strategy.
Michael’s experience doesn’t stop at CTMS implementations; it extends to multiple eTMF (Electronic Trial Management File) implementations, manufacturing, and other initiatives under the Life Science umbrella.
Michael is also skilled at developing the required validation documents to ensure compliance. This includes test scripts, use cases, requirements, Work Instructions, and SOPs.
Beyond the Life Science industry, Michael has managed a wide range of programs and projects within several industries and has been a part of PMO creation and uplift efforts.
He has also held multiple IT operational leadership positions.
“Mike is a seasoned pharmaceutical development project manager specializing in clinical system implementations. Mike has successfully implemented CTMS, eTMF, and safety databases for me and has completed each project on time and within specs and budget. Mike is that rare individual that knows the clinical space, project management and IT. He has been key to our team success”.
- Senior Director at Akebia Therapeutics
“I have been working with Mike for over a year now, and he has been stellar with fulfilling the systems needs in TMF/RIM (.e.g. migrations, system upgrades, add’l feature, etc.); all the while continuing to support other functional areas with their needs (e.g. Argus Safety System, DSPV Content Mgmt Room, etc.). Mike has a real grasp of technological systems and how they relate to clinical applications. He can bridge the gap between complex “IT speak” and still assess and determine how those systems can meet the needs of clinical. He listens to the team's needs/concerns compares that to what the technology can provide and when the two don’t quite meet, he finds real solutions for implementation. I’m always amazed when we are having a discussion with our Vendors during a migration, and there is a very technological concept that I don’t really understand. Mike will explain it to me in layperson terms without being condescending. He then listens to any questions or concerns I have and finds a solution one way or another.”
-Associate Director - Head RIM / TMF at Akebia Therapeutics
Other Testimonials
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Experienced in all regulator and validation requirements needed to ensure a successful implementation of clinical systems that are fully inspection ready for any agency audits.
SaaS vendor management
CTMS
eTMF
EH&S Material Compliance
Clinical study support systems
PMO Uplift efforts, with a LS regulation mindset.
Multiple migrations within LS
eTMF
Safety Databases
EH&S Manufacturing
Regulatory Inspection Readiness
Critical GxP System Documentation
Test Scripts
Requirments and Use Cases
Work Instructions and SOPs
For further Life Science experiences: Curriculum Vital
Testimonials
Pharmacovigilance Argus Safety DB Migration
“Mike has been a tremendous, thoughtful ally and has demonstrated his keen sense of humor, project management in times where high-pressure decisions are involved and also in keeping the project on the straight and narrow.”
GMP / CMC EHS Material Handling SaaS system
“Thanks for the diligent project management and keeping up with the tasks on a complex project. Coming into an area of EHS that you may not have been initially familiar with but then taking the challenge on within a complex tasks, a cross functional team of resources and managing to help deliver the activities is always commendable.”
Overall Program / Project Management Skills
“…he has the ability to tailor technical topics in a fashion that is appropriate for the level of the audience.”
“Through Michael efforts the division increased its performance and its relationship among other divisions thereby making the entire organization a better place to work.”
“Working with Mike made me a better Project Manager as I witnessed how well he managed all situations with ease and professionalism.”
“Mike consistently displayed his PM skills on a number of visible and strategically oriented projects. His projects all came in on or under budget, were delivered per the plan and per the scope. Mike has good interpersonal skills which he applies on a daily basis to stay on top of his projects”
“… is an excellent leader with a winning personality and strong technical and management background.”
“Michael was brought in to Sears to provide an infusion of external talent, versed in best practices, and motivating others through excellence. He accomplished that and more.”
“Mike is the most effective project manager that I have had the opportunity to work with.”
Clinical Space and Life Science Infrastructure Program / Project Management
“He has worked in very high visibility initiatives that required excellent communication with senior management as well as within his own team members. Not shy on challenging the status quo and is fully dedicated to meeting the customer's delivery expectations.”
“Mike brings a high level of project management expertise to all of his projects and is well versed in multiple facets of project life cycles.”
“I contracted Mike in 2010 as a Project Manager for one of the major initiatives in my applications development portfolio for Abbott clinical trial operations. At that time, he had to step in for a PM who had to take a sudden family leave and maintain the project schedule and scope with very little budget or knowledge transition. Mike went on to successfully manage four other projects for me…”
“Mike has an excellent project management track record that, when combined with his keen business sense and interpersonal skills, afford him the ability to be highly effective in a wide array of projects, businesses, and cultures.”
(For full references read more on LinkedIn)