Senior Program & IT Leadership for Boutique, Emerging & Mid-Size Pharma

Program & Project Management for CTMS, eTMF, CSV, and SaaS migrations in regulated life sciences—without large consulting firm overhead.

Clinical Systems Project and Program Management

Michael Rosenberg is a senior program and project management consultant specializing in pharmaceutical and life sciences digital transformation. He partners with biopharma, biotech, and clinical research organizations to modernize clinical systems, stabilize complex programs, and deliver compliant, scalable technology solutions across regulated environments.

Michael brings deep expertise in Clinical Trial Management System (CTMS) modernization, having led Phase 0 and full lifecycle CTMS replacement programs for enterprise organizations. His work includes legacy system decommissioning, eClinical platform implementation, system integration strategy, data flow optimization, vendor management, and clinical process reengineering to support end-to-end clinical operations.

His experience also spans multiple Electronic Trial Master File (eTMF) implementations, manufacturing and quality systems, and a broad portfolio of GxP-regulated life sciences platforms. As a recognized leader in Computer System Validation (CSV) and regulatory compliance, Michael has directed the development of:

  • Business and functional requirements

  • Validation and test scripts

  • SOPs and work instructions

  • Regulatory traceability documentation
    in alignment with FDA, ICH, 21 CFR Part 11, and global compliance standards.

In addition to his life sciences expertise, Michael has successfully led complex enterprise programs across multiple industries, contributed to PMO creation and maturity advancement, and served in senior IT operational leadership roles. His leadership style combines strategic oversight with hands-on delivery, enabling organizations to move faster while maintaining full regulatory compliance.

Michael works with organizations on a consulting and fractional leadership basis, providing expert support in:

  • CTMS & eTMF transformations

  • Digital clinical operations

  • Program recovery & turnaround

  • PMO strategy & execution

Read More On LinkedIn…

“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

“I had the pleasure of working with Mike during his time at Akebia Therapeutics, and I can say without hesitation that he’s one of the most capable, thoughtful, and dependable IT and PMO leaders I’ve worked alongside. Mike brings a rare blend of technical expertise, program discipline, and genuine partnership that makes him an invaluable asset to any organization.

He has an exceptional ability to translate complex business needs into clear, actionable IT strategies, all while maintaining focus on efficiency, quality, and collaboration. Mike consistently demonstrated strong leadership in governance, vendor management, and cross-functional alignment — helping to advance key business initiatives with precision and calm professionalism.

Beyond his impressive technical and project credentials, what truly sets Mike apart is his integrity and his unwavering commitment to the people he works with. Any team would be fortunate to have his expertise, mentorship, and steady hand guiding their programs forward.”

Melissa (Edwards) Strange MBA-HCM, CCMP

Associate Director Clinical Development Operational Excellence

Other Testimonials

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Core Expertise & Services

  • Regulatory Compliance & Computer System Validation (CSV): End-to-end validation leadership ensuring inspection-ready clinical and manufacturing systems for FDA, EMA, and global health authority audits

  • SaaS & Vendor Management: Strategic oversight of SaaS platform implementations, vendor selection, and vendor governance

  • Clinical Systems Leadership:

    • Clinical Trial Management Systems (CTMS) modernization & migration

    • Electronic Trial Master File (eTMF) implementation & optimization

    • Clinical Study Support Systems

    • Safety Databases

  • Manufacturing, EH&S & Quality Systems:

    • EH&S Manufacturing Systems & Material Compliance

    • GxP-regulated manufacturing and quality platforms

  • Life Sciences Program Leadership:

    • PMO creation & PMO maturity uplift with a strong life sciences regulatory mindset

    • Large-scale life sciences system migrations & transformations

  • Regulatory Inspection Readiness:

    • Audit preparation, remediation, and regulatory inspection support

  • Critical GxP Documentation Development:

    • Business & functional requirements and use cases

    • Validation test scripts

    • Work instructions & SOPs

    • Traceability and compliance documentation

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)