Bachelor's degree in a business, technical, or relevant life sciences field; advanced degree preferred., At least 7 years of experience as a Project Manager in the pharmaceutical or clinical trials industry., Strong knowledge of Good Clinical Practice (GCP) guidelines and regulations, and familiarity with Software Development Lifecycle (SDLC)., Exceptional organizational, communication, and interpersonal skills with a strong aptitude for data analytics..
Key responsabilities:
Lead and oversee the planning, execution, and delivery of large and complex RBQM projects.
Monitor project timelines, budgets, and quality standards across multiple projects.
Collaborate with internal and external partners, establishing relationships with key stakeholders and decision makers.
Ensure all project deliverables are of high quality and exceed client expectations in compliance with Quality Management procedures.
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CluePoints is the premier provider of RBQM and data quality oversight software. We’re leveraging the potential of AI using advanced statistics and ML to determine the quality, accuracy, and integrity of clinical trial data both during and after the study. Aligned with guidance from the FDA, EMA, ICH, and MHRA, CluePoints supports central and on-site monitoring, medical review, and quality risk management to drive a holistic risk-based strategy.
Coupled with thought leadership and consulting expertise to aid risk assessment and solution implementation, the result is positive clinical development outcomes, increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
To learn more about CluePoints, visit CluePoints.com.
CluePoints is a fast-growing company and the premier provider of Risk-Based Monitoring and Data Quality Oversight solutions to clinical research organizations. Our products enable both risk planning and operational risk monitoring, and utilize advanced statistical algorithms to determine the quality of clinical trial data both during and following study execution. CluePoints is seeking outstanding candidates with strong project management skills and a passion for delivery excellence, to help drive customer success and broad adoption of the CluePoints solution.
Bachelor's degree in a business, technical, or relevant life sciences field; advanced degree preferred At least 7 years of experience as a Project Manager in the pharmaceutical or clinical trials industry, experience working for a SaaS company would also be considered In-depth knowledge of clinical trial phases, regulatory guidelines, and pharmaceutical development processes Strong knowledge of Good Clinical Practice (GCP) guidelines and regulations Familiarity with Software Development Lifecycle (SDLC) and/or Risk Based Quality Management (RBQM) Strong financial acumen with experience managing project budgets
Proficiency in project management methodologies and tools, able to teach others project management basics
Exceptional organizational and time management abilities with an emphasis on successfully managing multiple competing priorities while remaining professional and respectful to all organization levels
Ability to resolve conflicts and manage stakeholder expectations
Capable of identifying and weighing risks and making informed decisions that align with CluePoints values and strategy
Strong aptitude for data analytics and basic statistical concepts
Excellent communication, negotiation, and interpersonal skills with an emphasis on demonstrating professional and respectful interactions with all organization levels
Strong organizational skills with prior experience in project management
Effective communication skills, including verbal, written and presentation skills
Experience working in a team environment under time and resource constraints
Flexible and adaptable to changing priorities
Highly proficient with MS Office tools (Excel, PowerPoint, Project)
Aptitude for data analytics and data processing
Ability to travel for Business
Lead and oversee the planning, execution, and delivery of large and complex RBQM projects
Oversee, develop, and manage complex project plans, timelines, budgets, and resources with dependencies across multiple projects
Monitor project timelines, budgets, and quality standards across multiple projects
Identify and mitigate project risks, issues, and deviations from project plans
Drive cross-functional teams to ensure successful project outcomes
Provide strategic guidance and direction to project teams, ensuring project goals are met
Collaborate with internal and external partners including clinical research organizations, sponsors, and vendors, establishing relationships with key stakeholders and decision makers
Ensure all project deliverables are of high quality and exceed client’s expectations in compliance with Quality Management procedures
Actively lead and contribute to the development of highly effective training plans and content, and as project lead, ensure other project team members do the same
Provide basic training to clients on CluePoints solution
REASONS TO JOIN US
Flexibility is part of our DNA
Many activities are organized during the year such as team lunches, happy hours, team buildings, holiday parties and many other celebrations!
At CluePoints, learning, training and personal growth are part of the game: you’ll have access to online training materials, certifications sponsored by the company, personal growth plans, and career paths to explore new opportunities.
You’ll work with a fast-growing, multi-disciplinary and international team representing over 20 different nationalities, in an English-speaking working environment.
You’ll have a challenging and rewarding job in an ambitious and fast-paced technology scale-up that has received many national and international awards including “Scale-Up of the year 2019”!
Competitive salary & benefits
Required profile
Experience
Spoken language(s):
English
Check out the description to know which languages are mandatory.