Protecting your Clinical Data with Expert Fractional Leadership
Tailored Strategies for Biotechs
I help early stage biotechs avoid preventable data and vendor issues so their studies stay on track and their data is submission ready without delays or rework.
1
Stabilizing complex, vendor‑heavy studies with senior, single‑threaded ownership that keeps data and operations on track.
2
Ensuring inspection‑ready data quality through expert oversight and early risk detection.
3
Creating confident execution by aligning teams and restoring operational discipline.
I help biotechs achieve on time delivery in less time:
Direct, senior-level delivery — no hand-offs, just reliable results.
Unified workflow — aligning clinical, data, biostats, and vendors to minimize issues.
Early risk detection — identifying and resolving problems before they impact timelines.
TESTIMONIALS
What others are saying
Maureen Maunsel
Associate Director, Data Management at Moderna
I had the pleasure of working with Helen at two previous employers and can’t recommend her highly enough. I can confidently say that she is an exceptional leader in Data Management. Her depth of knowledge and commitment to improving processes truly set her apart.
Beyond her technical expertise, Helen is an incredibly patient and supportive mentor. She played a significant role in helping me grow into a more well-rounded data manager, and I’m grateful for the guidance and perspective she provided.
Any team would be fortunate to have her.
Sara Gopal, PMP
Strategic leader, problem solver, innovative thinker, relationship builder, adaptable
I have known Helen for more than 8 years in a professional capacity and find Helen to be a knowledgeable project manager who is an expert in Data Management. I had the pleasure of partnering with Helen on a project for Six Sigma certification. We worked together on making the study start-up process more efficient and enjoyed collaborating with her.
Helen has a "can do" personality, which is critical in the CRO industry. I would highly recommend Helen for any Project Management position.
Patricia Casa Santa, RHIA
Lead Data Manager for Global Clinical Trials
Helen has extensive experience in the pharmaceutical research industry with a focus on Clinical Data, Project, Financial, and Personnel Management. She was entrusted to develop a Data Management team in Canada and readily traveled domestically and internationally on company business, often on the spur of the moment.
She is a dedicated professional who is admired and respected by all who interact with her. She was readily available to share her expertise and mentored a successful team. Helen demonstrates calmness under pressure that is admired.
She will be an asset to any organization.
Anthony Emma
Director, Portfolio Resourcing Analytics & Innovation
I would strongly recommend Helen. I worked with Helen for a couple of years, and it was always a good experience. Helen is an individual who takes the time to do a great job.
The organization of data management and specifically resource management was better positioned for resource challenges due to Helen's efforts.
Alexis Gianelos
Global Clinical Operations, Data Management & Program Leader | Portfolio Delivery • People Leadership • Operational Excellence
I cannot express enough what a pleasure it was working directly with Helen. I found Helen to be a proactive and tireless contributor who would make a great addition to any company.
She is highly knowledgeable within the CRO industry and understands all aspects of Data Management, Project Management, and Costing activities. Helen has also helped mentor others, including myself. She had a great knack for taking her time and explaining things thoroughly and would always be available for any follow-up questions you may have.
I would highly recommend Helen.
Kari Ruconich, MBA
Senior Strategic Proposal Development, Biotech Solutions
I have been at Covance for over 8 years and Helen Fasshauer has and continues to be an expert in her field. Helen's expertise is not only valued by internal team members, but her professionalism and superior knowledge around clinical data management has proven time and time again to be key for external clients.
If any additional information is required, I'd be happy to provide further recommendations for Helen!
Kari Harmon, MBA
Associate Director, Late Stage and CMA Client Services
Covance Inc.,
Clinical Development Services
Theo Amenyenu, MS
Senior Clinical Research Data Specialist
Helen is a very good Project Director. She is great about keeping an eye on the details across several different projects, clients, team members, and responsibilities while also understanding the big picture and helping the team remove obstacles and meet deadlines.
Helen is always calm and inspires everyone to go above and beyond to ensure clients are satisfied with deliverables. Her approachable and friendly demeanor makes her a great leader and team member on all projects.
Helen’s vast knowledge of the industry and technical understanding has helped projects move more efficiently throughout the organization. She has always formed lasting relationships across functional groups and with people at all levels in the organization, making her a great asset to any organization.
I've really enjoyed working with Helen and would do so in any situation without question.
Marian McCaffrey
Associate Director, Process & Personnel Qualification Management Expert
I worked with Helen often during my time as a Quality Manager at Covance. My interaction with her was always positive. She displayed great insight regarding any issue, and I respected her sound judgment.
In my quality role, if action was needed to address a quality concern, I was confident that Helen would take the issue at hand and address it promptly to a positive resolution. Despite being in two different locations, we worked very well together.
She was the consummate professional and had a great rapport with both her team and other groups within the organization. She would be an asset to any organization.
TESTIMONIALS
What others are saying
Maureen Maunsel
Associate Director, Data Management at Moderna
I had the pleasure of working with Helen at two previous employers and can’t recommend her highly enough. I can confidently say that she is an exceptional leader in Data Management. Her depth of knowledge and commitment to improving processes truly set her apart.
Beyond her technical expertise, Helen is an incredibly patient and supportive mentor. She played a significant role in helping me grow into a more well-rounded data manager, and I’m grateful for the guidance and perspective she provided.
Any team would be fortunate to have her.
Sara Gopal, PMP
Strategic leader, problem solver, innovative thinker, relationship builder, adaptable
I have known Helen for more than 8 years in a professional capacity and find Helen to be a knowledgeable project manager who is an expert in Data Management. I had the pleasure of partnering with Helen on a project for Six Sigma certification. We worked together on making the study start-up process more efficient and enjoyed collaborating with her.
Helen has a "can do" personality, which is critical in the CRO industry. I would highly recommend Helen for any Project Management position.
Patricia Casa Santa, RHIA
Global Clinical Operations, Data Management & Program Leader | Portfolio Delivery • People Leadership • Operational Excellence
Helen has extensive experience in the pharmaceutical research industry with a focus on Clinical Data, Project, Financial, and Personnel Management. She was entrusted to develop a Data Management team in Canada and readily traveled domestically and internationally on company business, often on the spur of the moment.
She is a dedicated professional who is admired and respected by all who interact with her. She was readily available to share her expertise and mentored a successful team. Helen demonstrates calmness under pressure that is admired.
She will be an asset to any organization.
TESTIMONIALS
What others are saying
Maureen Maunsel
Associate Director, Data Management at Moderna
I had the pleasure of working with Helen at two previous employers and can’t recommend her highly enough. I can confidently say that she is an exceptional leader in Data Management. Her depth of knowledge and commitment to improving processes truly set her apart.
Beyond her technical expertise, Helen is an incredibly patient and supportive mentor. She played a significant role in helping me grow into a more well-rounded data manager, and I’m grateful for the guidance and perspective she provided.
Any team would be fortunate to have her.
Sara Gopal, PMP
Strategic leader, problem solver, innovative thinker, relationship builder, adaptable
I have known Helen for more than 8 years in a professional capacity and find Helen to be a knowledgeable project manager who is an expert in Data Management. I had the pleasure of partnering with Helen on a project for Six Sigma certification. We worked together on making the study start-up process more efficient and enjoyed collaborating with her.
Helen has a "can do" personality, which is critical in the CRO industry. I would highly recommend Helen for any Project Management position.
Patricia Casa Santa, RHIA
Global Clinical Operations, Data Management & Program Leader | Portfolio Delivery • People Leadership • Operational Excellence
Helen has extensive experience in the pharmaceutical research industry with a focus on Clinical Data, Project, Financial, and Personnel Management. She was entrusted to develop a Data Management team in Canada and readily traveled domestically and internationally on company business, often on the spur of the moment.
She is a dedicated professional who is admired and respected by all who interact with her. She was readily available to share her expertise and mentored a successful team. Helen demonstrates calmness under pressure that is admired.
She will be an asset to any organization.
Anthony Emma
Director, Portfolio Resourcing Analytics & Innovation
I would strongly recommend Helen. I worked with Helen for a couple of years, and it was always a good experience. Helen is an individual who takes the time to do a great job.
The organization of data management and specifically resource management was better positioned for resource challenges due to Helen's efforts.
Alexis Gianelos
Global Clinical Operations, Data Management & Program Leader | Portfolio Delivery • People Leadership • Operational Excellence
I cannot express enough what a pleasure it was working directly with Helen. I found Helen to be a proactive and tireless contributor who would make a great addition to any company.
She is highly knowledgeable within the CRO industry and understands all aspects of Data Management, Project Management, and Costing activities. Helen has also helped mentor others, including myself. She had a great knack for taking her time and explaining things thoroughly and would always be available for any follow-up questions you may have.
I would highly recommend Helen.
Kari Ruconich, MBA
Senior Strategic Proposal Development, Biotech Solutions
I have been at Covance for over 8 years and Helen Fasshauer has and continues to be an expert in her field. Helen's expertise is not only valued by internal team members, but her professionalism and superior knowledge around clinical data management has proven time and time again to be key for external clients.
If any additional information is required, I'd be happy to provide further recommendations for Helen!
Kari Harmon, MBA
Associate Director, Late Stage and CMA Client Services
Covance Inc.,
Clinical Development Services
Marian McCaffrey
Associate Director, Process & Personnel Qualification Management Expert
I worked with Helen often during my time as a Quality Manager at Covance. My interaction with her was always positive. She displayed great insight regarding any issue, and I respected her sound judgment.
In my quality role, if action was needed to address a quality concern, I was confident that Helen would take the issue at hand and address it promptly to a positive resolution. Despite being in two different locations, we worked very well together.
She was the consummate professional and had a great rapport with both her team and other groups within the organization. She would be an asset to any organization.
Theo Amenyenu, MS
Senior Clinical Research Data Specialist
Helen is a very good Project Director. She is great about keeping an eye on the details across several different projects, clients, team members, and responsibilities while also understanding the big picture and helping the team remove obstacles and meet deadlines.
Helen is always calm and inspires everyone to go above and beyond to ensure clients are satisfied with deliverables. Her approachable and friendly demeanor makes her a great leader and team member on all projects.
Helen’s vast knowledge of the industry and technical understanding has helped projects move more efficiently throughout the organization. She has always formed lasting relationships across functional groups and with people at all levels in the organization, making her a great asset to any organization.
I've really enjoyed working with Helen and would do so in any situation without question.
Catherine Sanderson
Former Associate Director at Covance
Helen had sole responsibility for my training and mentoring while developing the new Data Management department in our office. She continued that mentoring for me, regardless of reporting structure, for over 15 years; always willing to listen, encourage, and assist with growth opportunities.
Her consistent compassion, patience, and calm demeanor are admirable and made her an excellent manager and mentor. The leadership and costing development skills she exhibited have been a positive example for the department and assisted me greatly in my professional development.
Anders Eriksson
CFO
Helen is great to work with. She is very team-oriented and always ready to help. I worked with her extensively in a cross-functional capacity to align pricing algorithms for data management tasks.
She is very thoughtful and patient, has a great attitude, and is excellent at explaining herself. She is a delight to work with, and I would definitely recommend her.
Sachi Amatya
Clinical Data Strategy & Management Leadership | CCDM, Ed.D., MBA
I have worked with Helen directly on several clinical trials. She was the senior data manager on these studies. She is an amazing mentor and an inspiring manager.
As Director of Data Management, Helen took a genuine interest in the growth of all group members and was personally responsible for ensuring that the group functioned as a cohesive team. Under Helen's capable leadership, we were able to achieve extraordinary results both as individuals and as a team.
I have learned a great deal from her about management and leadership. Helen possesses encyclopedic knowledge of data management, project integration, and business development. She is highly detail-oriented and results-driven.
I am confident that she will be an invaluable asset to any organization she joins.
Brittany Spradling
President of ESP, LLC
Helen is one of the most detail-oriented colleagues I have worked with. She served as the manager of my manager. Though two levels above my position, Helen was able to mentor me directly whenever my manager was not available.
She never showed hesitation in taking the time to work with me on matters relating to our shared clients or even in how to best handle GCP matters where I needed guidance.
Helen has a special ability to not only manage on a very high level but also flip the switch to walk directly beside her employees as their mentor.
Any company hiring Helen would be lucky to have her.
Sharon Henkel
Senior Director, Business Operations, Development Operations & Program Management
Helen is a client-focused, quality-driven leader with expert clinical data management experience. She manages through complex projects with drive and determination while maintaining the utmost quality expected of her and her team.
I was fortunate to work with Helen on multiple complex, high-priority projects, and her ability to deliver quality results within given timelines was superb.
Helen is highly regarded by those who work for her, those who are her peers, and those who are her clients. Helen’s technical expertise, along with her ability to effectively interact with clients, makes her a strong asset to any organization.
Dr. Madhuri Patel
Clinical Research
Helen is an exceptional clinical data management professional whose technical proficiency is complemented by an unwavering commitment to excellence.
Having collaborated with her for years, I have seen firsthand her ability to navigate complex data ecosystems with ease and precision. She is incredibly disciplined, proactive, and consistently goes above and beyond to ensure project success.
If you are looking for a data manager who brings both deep expertise and a tireless work ethic, Helen is the professional you need.
Megan Malloy
Associate Director, Data Management Leader at Johnson & Johnson
Helen is a very detail-oriented person. She is also very organized. She served as the Data Services Project Manager on a couple of my projects and was wonderful.
She managed timelines efficiently and effectively. She often saw the big picture of all the functional groups and how they all related to each other and affected project timelines.
She worked very well with clients and was always a professional. She multitasked very well.
Joanne Connelly (DeVoti)
Director Business Operations, Life Sciences, MBA
Helen has always been a pleasure to work with and has been the subject matter expert in her department. Helen is a great mentor and has always been accessible to provide guidance and answer questions.
As a director, Helen has guided and trained her team, and in turn, her team has always held her in the highest regard. Helen is detail-oriented and provides accurate analysis. She has strong communication and organizational skills.
Those skills are reflected in her experience working with cross-functional teams, where she has taken on leadership roles and earned the respect of her colleagues.
Stan Bouton, PMP
Project/Program Management Implementation, Data Analytics and Data Management
Helen is a dedicated Project Manager who understands the nuances of Clinical Data Management and Drug Development. It has been a pleasure working with her. She sets a strong example of organizational commitment and inspires loyalty and dedication in others.
Helen is detail-oriented and well-liked by her colleagues and direct reports. She is a multitasker who has successfully handled multiple projects simultaneously. She is highly methodical in her planning strategies and maintains a level head even in the most stressful situations.
I would highly recommend Helen as a Project Manager or Line Manager, as she treats people fairly, professionally, and with respect. She is a team player who works alongside junior staff and guides the team toward success.
Helen is extremely open to change and to suggestions from others. She is one of the most versatile managers I have had the pleasure to work with.
Francois Le Barbenchon
Senior Study Manager (Oncology) at ICON on assignment with Merck
Helen is a calm and detail-oriented person whom you can always count on to get things done. She is extremely knowledgeable in all data management functions, and her people skills enable her to lead others toward achieving key client deliverables, especially when it comes to database locks.
She is also able to manage several priorities as client needs shift. Her calm demeanor helps diffuse high-pressure situations.
Helen would be a valuable addition to any team.
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