China · Remote OK
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of b…
Skills: Regulatory Submissions, Site Start-Up, ICH-GCP, Clinical Trial Application, Informed Consent Form Review
Netherlands · Remote OK
Here at Precision AQ we are building a Data Hub, a centralized platform team, to be responsible for consolidating legacy data infrastructure, establishing enterprise data foundation and governance and enabling AI/ML capa…
Skills: Engineering Leadership, Data Engineering, Platform Engineering, Analytics Engineering, Snowflake
United Kingdom · Remote OK
Here at Precision AQ we are building a Data Hub, a centralized platform team, to be responsible for consolidating legacy data infrastructure, establishing enterprise data foundation and governance and enabling AI/ML capa…
Skills: Engineering Leadership, Data Engineering, Platform Engineering, Analytics Engineering, Snowflake
United States · Remote OK
$91k–$137k/yr
Position Summary: The Associate Manager, Client Finance will review & manage the overall financial management for our client portfolio, reporting, general day-to-day activities, and related month end close duties. Essent…
Skills: Project Accounting, Financial Reporting, Revenue Recognition, Budgeting, GAAP
United States · Remote OK
$53k–$79k/yr
At Precision AQ, our Associate Program Managers play a critical role in bringing client programs to life—ensuring projects run smoothly, deadlines are met, and teams stay aligned every step of the way. This is an excitin…
Skills: Project Management, Client Relationship Management, Budget Tracking, MLR Submissions, Microsoft Office
China · Remote OK
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of b…
Skills: Clinical Project Management, Budget Management, Risk Management, ICH-GCP, Vendor Management
Bangalore, Karnataka, India · On-site
Job Summary and Purpose: The People Operations Partner provides in-country-specific HR operational expertise within the global HR operating model. Acting as the Tier 2 operational HR lead for their assigned country, the …
Skills: HR Operations, Employee Relations, Employment Legislation, Compliance Management, Stakeholder Management
Australia · Remote OK
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of b…
Skills: Site Management, Clinical Monitoring, ICH-GCP, Patient Safety, Regulatory Compliance
Berlin, Germany · On-site
Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authoriti…
Skills: Sample Processing, Epigenetic qPCR Markers, Bisulfite Conversion, DNA Purification, qPCR Analysis
Mexico, Chihuahua, Mexico · Remote OK
Position Summary: This position is a hybrid between a project budget analyst supporting the operational project teams financially, and an accountant supporting all general ledger functions and the month-end close cycle. …
Skills: Financial Analysis, General Ledger, Month-end Close, Variance Analysis, Earned Value Analysis
Mexico, Chihuahua, Mexico · Remote OK
We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM! Our TMF…
Skills: TMF Management, Good Clinical Practice (GCP), eTMF Systems, FDA Regulations, ICH Guidelines
Slovakia · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
Serbia · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
United Kingdom · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
Romania · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
Poland · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
Hungary · Remote OK
Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in UK, Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precisio…
Skills: Clinical Trial Management, Oncology, GCP/ICH Guidelines, Site Selection, Enrolment Management
India · Remote OK
Position Summary: The candidate will be responsible for supporting software quality assurance across applications, platforms, and business units. The role involves designing and executing test cases, developing and maint…
Skills: Automation Testing, Selenium, Playwright, Cypress, Java
Hungary · Remote OK
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of b…
Skills: Clinical Monitoring, Site Management, ICH-GCP, Regulatory Submissions, Conflict Resolution
Spain · Remote OK
Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and …
Skills: Clinical Monitoring, Site Management, ICH-GCP, Oncology Monitoring, Regulatory Submissions
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Manage regulatory and site start-up activities, including submissions to Competent Authorities and Ethics Committees to ensure timely site activation. Coordinate the collection of essential documents and support budget and contract negotiations for clinical trials.
Requires a Bachelor's degree in life sciences or a related field and at least one year of experience as a Regulatory or Start-Up specialist in a CRO or pharmaceutical environment. Fluency in English and the local language of the based country is required.
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist.
The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.
Essential functions of the job include but are not limited to:
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.
Requirement:
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
Offices: 2 Bethesda Metro Center, Suite 850, Bethesda, Maryland 20814, US
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
Offices: 2 Bethesda Metro Center, Suite 850, Bethesda, Maryland 20814, US
