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Alethea Wieland

Founder and President of Clinical Research Strategies

 

Alethea Wieland

Alethea Wieland

Founder and President of Clinical Research Strategies

Alethea Wieland is Founder and President of Clinical Research Strategies, LLC, an executive-level management consulting firm for the life science industry established in 2011. Her career spans more than two decades in the pharmaceutical, medical device, IT/healthcare, and contract research organizations (CROs) industries with specialties in start-ups.  She is a subject matter expert (SME) in clinical operations, regulatory strategy and face-to-face negotiations with the FDA and competent authorities, corporate compliance, business ethics and privacy, and FDA inspection-readiness. Between 2015-18, she led the start-up of the North American operations of a parent EU company by managing all legal, IT / server, equipment and asset management, leases, banking, insurance, corporate policies, payroll, benefits and retirement plan, human resources, talent recruitment and onboarding, and operational organization.

Alethea’s focus today is on training and managing resilient, high-performing clinical operations teams, and mitigating risks of clinical trials by facilitating the best Sponsor-CRO partnerships who practice accountability and transparency. She is an advocate of frequently meeting with regulators and stakeholders which results in a win-win mindset.

Alethea volunteers her time with hackathon judging, mentoring Pitt and CMU entrepreneurs, and meeting with mentees in the local chapter of Women in Bio (WIB).

Alethea is the 2017 WIB P.O.W.E.R. award recipient and was recognized by Pittsburgh City Council and Governor Tom Wolf for her contributions to the life science industry in Pennsylvania.

Her clients and partners include CROs, medical device and biotechnology companies, AI/Blockchain start-ups, healthcare IT companies, and mid- and senior-level clinical or regulatory affairs professionals seeking exclusive positions in industry.

Learn more by connecting with her in LinkedIn (https://www.linkedin.com/in/alethea/), and by visiting her website at www.clinicalresearchstrategies.com.