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KVALITO Consulting Group
is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in- depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry- leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch.
Life Science Consultant, Project Manager- Bioequivalence Studies
Location:
Vietnam
Job Summary
The Project Manager for Bioequivalence Studies plays a critical role in planning, executing, and overseeing bioequivalence studies aimed at assessing the interchangeability and safety of generic drug formulations with their brand- name counterparts. This role requires a blend of project management expertise, regulatory knowledge, and scientific understanding to ensure the successful completion of studies that impact pharmaceutical product development and patient safety.
Key Responsibilities
Study Planning and Design:
Collaborate with cross- functional teams to define study objectives, scope, and deliverables.
Develop comprehensive study protocols and ensure alignment with regulatory requirements and industry best practices.
Coordinate the selection of appropriate clinical sites and investigators.
Regulatory Compliance
Stay current with global regulatory guidelines related to bioequivalence studies (e.g., FDA, EMA) and ensure adherence throughout the project.
Prepare and submit regulatory documents, including Investigational New Drug (IND) applications or Investigational Medicinal Product Dossier (IMPD) as required.
Resource Management
Allocate resources effectively, including personnel, budget, and equipment, to ensure the timely and efficient execution of studies.
Monitor and manage project timelines, milestones, and budgets.
Study Execution
Implement quality control measures to maintain data integrity and compliance with Good Clinical Practice (GCP) standards.
Coordinate sample collection and analysis, including pharmacokinetic assessments.
Oversee the recruitment and enrollment of study participants, ensuring adherence to inclusion and exclusion criteria.
Data Analysis And Reporting
Prepare comprehensive study reports, including statistical analyses, for regulatory submissions.
Collaborate with statisticians and data analysts to interpret study results and draw conclusions regarding bioequivalence.
Communication And Collaboration
Maintain clear and effective communication with internal teams, external partners, clinical investigators, and regulatory agencies.
Act as a liaison between project stakeholders, ensuring alignment with project goals.
Risk Management
Proactively manage and resolve issues that may impact study progress.
Identify potential risks and develop mitigation strategies to address study challenges.
Continuous Improvement
Conduct post- study reviews to identify lessons learned and opportunities for optimization.
Stay informed about advances in bioequivalence study methodologies and recommend improvements to enhance study efficiency and quality.
Minimum Qualifications And Experience
Education
A Bachelor&039;s or Master&039;s degree in a relevant scientific field (Pharmacy, Pharmacology, Life Sciences, etc.).
Qualifications
Excellent project management skills, including the ability to manage multiple projects simultaneously.
Proven experience in managing bioequivalence studies or clinical trials, preferably in the pharmaceutical industry.
Familiarity with statistical analysis software and data management tools is a plus.
Certification in project management (PMP) is desirable but not required.
Attention to detail, problem- solving abilities, and a commitment to data integrity and patient safety.
Strong communication and interpersonal skills for effective collaboration with cross- functional teams.
Strong knowledge of regulatory requirements and guidelines related to bioequivalence studies.
We Offer Great Benefits
Individual professional development, training, and coaching
Diversity and inclusion- focused environment
Involvement in global conferences
Excellent remuneration package consisting of a competitive salary plus a substantial bonus
Unlimited full employment contract
People- oriented culture
Flat hierarchies and responsibility from the beginning
Flexible working hours and home office
Global client projects in a multinational environment
Contact
Responsibilities
If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:
Location preference
Availability- earliest start date
Salary expectations
CV, cover letter and supporting documents (i.e., diplomas, certificates, references)
We are looking forward to your application.
Your KVALITO Team.
