Alet Van Beek Email & Phone Number

Bedford, Ma, Us

Pittsburgh, Pennsylvania, Us

• Build a global group responsible for inspection readiness and management at ~1800 investigator sites across multiple therapeutic areas including diabetes, rheumatology, oncology, dermatology, and ophthalmology utilizing a risk-based approach and CRO metrics.• Lead a global rescue effort in inspection preparation on an acquired asset that demonstrated the futility of a submission and implemented lessons learned from the experience to enforce the need for continues improvement.• Design and implement a QMS including global SOPs and role-based training curricula that improved compliance leading to successful inspection outcomes.• Facilitate proactive gap analysis and provide guidance to develop strategies to mitigate risks leading to increased inspection readiness. • Lead design, implementation and training of a CTMS and eTMF providing custom reports for regulatory purposes, and comprehensive data for managerial decision making.• Spearheaded efforts to integrate documents and data from acquired assets in paper and e-format.

Princeton, Nj, Us

• Interacted with health authority (FDA, EMA, and PMDA) for protocol development achieving a globally acceptable program that supported multiple filings.• Networked with global key opinion leaders to develop clinical trials and build relationships that led to faster enrollment.• Devised and executed novel recruitment strategies to reach scarce patient population ensuring timely completion of the trial.• Collaborated on medical review and clinical study report writing confirming accuracy and completeness.• Led multidisciplinary group to ensure quality and consistency in data and filing processes eliminating lost time due to errors and cost overruns.• Focused on proactive planning to minimize and mitigate risk to the programs, with decisive issue escalation and resolution.• Contributed to various company initiative to integrate and optimize innovate e-solutions in clinical trial conduct including e-consent and ingestible sensors.• Managed, trained and mentored team members leading to career growth and promotions for some team members.

New York, New York, Us

• Instilled concepts of quality management and pro-active inspection readiness planning to ensure global clinical trials are conducted to internal and external standards and can withstand regulatory inspection.• Led operational response team to a FDA Warning Letter and implementation of preventative steps providing a solid foundation for improvement and resulting in decreased compliance issues. This lead to the successful relaunch of a pediatric program.• Contributed to a FMEA on a critical quality issue as operations expert leading to the overhaul of operational processes and decreasing the risk of future events.

Princeton, Nj, Us

• Managed resources of approximately 25 Otsuka staff and 50 CRO employees (incl. vendors and multiple other departments i.e. project planning, data management, clinical supplies, and statistics/programming) implementing efficiencies and optimizing efforts leading to successful execution, filing and obtaining the 7 year additional patent extension.• Initiated a clinical program in Asian countries leading to Japanese filing.• Contributed to NDA/MAA filing preparation and labelling activities.

Lawrence Township, Nj, Us

Lead cross-functional teams to ensure the successful execution of multiple global clinical trials (for a new indication and new formulations) from study design through reporting. Monitored multiple studies across therapeutic areas. Managed a team of 5 CRAs at country level.

Indianapolis, Indiana, Us

Master’S Degree, Master Of Science (Ms), Regulatory Affairs In Small Molecules, Biologics And Medical Devices

Bsc Honns, Radiobiology

Bachelor Of Science (Bsc) Honns, Radiobiology