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Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patientsâ lives. Optimapharmâs key priorities are our people and consistently exceeding our clientâs expectations.
With 26 strategically located offices across Europe, Optimapharm gives unrivalled access to Patients and Investigators worldwide.
In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
Companies Figures
âą 510+ staff members
âą Excellence in delivery and superior project performance with an investigator network of 1000+ active sites
âą Close client relationship & high client retention rate of 85%
âą Highly educated workforce & low staff turnover rate; less than 15%, across the organization
âą Regional Cost-effective solutions
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Full-service study delivery, Stand-alone service and Functional Service Provider are the 3 pillars Optimapharm offers to best respond to planned clinical development and efficiently resource clinical projects.
âą Regulatory Affairs
âą Medical Affairs
âą Medical Writing
âą Clinical Monitoring
âą Project Management
âą Data Management
âą Biostatistics
âą Safety and Vigilance
âą Quality
âą Translation Services
OPTIMAPHARM's offices:
- Austria
- Belgium
- Bosnia and Herzegovina
- Bulgaria
- Croatia
- Czech Republic
- Estonia
- Finland
- France
- Georgia
- Germany
- Greece
- Hungary
- Lithuania
- Republic of North Macedonia
- Moldova
- Poland
- Romania
- Serbia
- Slovenia
- Spain
- Sweden
- Switzerland
- The United Kingdom
- The United States of America
Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patientsâ lives.
Optimapharmâ s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.
With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators in all countries in Europe and North America. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.
We are seeking an accomplished Senior Regulatory and Start-Up Specialist (Sr RSUS) to join our expanding team in US. If you are a detail-oriented professional with a deep understanding of regulatory submissions and site startup strategies, and you thrive on driving clinical trial success, we want to hear from you!
đ What do we offer?
Working in a successful company thatâs growing and developing every day
Company that supports life balance
Company with healthy culture
Working with a highly experienced team of clinical research professionals
Competitive salary
Competitive PTO entitlement
Health insurance, including vision and dental plans, to meet your and your family's needs
Comprehensive pension plan to maximize savings and prepare confidently for the future
Employee engagement programs
Well-being initiatives
Training and development program
Fast-paced career path progression
đ Who are we looking for?
đŒ Qualifications And Experience
University degree in Medicine, Pharmacy, Life Sciences, or equivalent combination of education, training, and experience
At least 4 years of experience in regulatory and start-up activities with proven expertise and strong knowledge of Ethics, including central IRB submissions, Site Contract & Budget negotiations, and Safety reporting requirements
Comprehensive understanding of the drug development process, GCP, ICH Guidelines, ISO 14155, and relevant IRB clinical investigation guidelines
Knowledge of local regulatory requirements/guidelines/ personal data privacy laws and international industry standards (GCP ICH and CFR FDA Regulations)
Experience in clinical research within CROs and/or BioPharmaceutical settings, including site contracts & budget negotiation, and team collaboration
Proficiency in computer systems (e.g., Excel), technical problem-solving, and the ability to manage abstract and complex variables
Strong written, oral, administrative, and presentation skills; ability to communicate effectively with internal and external stakeholders
Skilled in time management, multitasking, and working independently in fast-paced, team-oriented environments
Affinity for mentoring and supervising, with a proactive, diplomatic, and reliable approach
Strong problem-solving, negotiation, and customer service skills, with a focus on building relationships and achieving results
đ Your responsibilities
Oversee & support the sites with IRB submissions for clinical trials in compliance with applicable laws, regulations, and guidelines, including SOPs, GCP, ISO 14155, and FDA/IRB guidelines.
Negotiate, manage, and administer site contracts and budgets, including agreements with institutions, principal investigators, study site staff, and external facilities involved in study conduct.
Prepare and implement country-level study submission and site startup strategies.
Provide input on project plans, documents, and guidelines.
Act as the primary Client/Project contact for assigned countries/sites during the start-up phase.
Serve as a point of contact for country-specific regulations and processes.
Mentor newcomers and train team members on country-specific SOPs, work instructions, and submission processes.
Develop training presentations and participate in the creation of SOPs/WIs.
Prepare and review essential documents required for Investigational Medicinal Product or Device release to investigational sites.
Manage submissions of periodic or local safety reports to ethics committees and regulatory authorities in compliance with relevant laws and regulations.
If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.
Required profile
Experience
Level of experience:Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.