Precision For Medicine

Clinical Research

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations, and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams with larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

Senior Clinical Research Associate

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators and helping prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support clinical study teams on larger-scope trials
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies, including identifying investigators, helping prepare regulatory submissions, and conducting pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators and help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical trials with clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate study setup and monitoring activities
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations
• Build the company’s network of experienced clinical research professionals for future project requirements

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators
• Help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

Compliance

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and/or review submission documents for Regulatory Authorities and Ethics Committees
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

Regulatory Manager – Senior Regulatory Manager

• Provide regulatory strategy and development guidance throughout clinical trials
• Guide regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Develop and/or review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and/or review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; update Regulatory Leadership
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Prepare and coordinate well-organized, high-quality regulatory submissions in compliance with applicable regulations
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and review submission documents for compliance with regulatory standards
• Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
• Work within project teams and lead projects for a region or globally when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Develop and review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at internal and external project team meetings
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and/or review submission documents to assure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings

Regulatory Manager / Senior Regulatory Manager

• Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate document translations and coordinate translations required for submissions
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews
• Support study budget negotiations and investigator contract execution when required
• Support feasibility activities and site outreach when needed
• Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
• Maintain audit/inspection readiness and file documents according to TMF and study-specific plans
• Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring
• Perform other duties assigned by management

Regulatory and Site Start-Up Specialist

Manager

• Review, draft, negotiate and track legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Support maintenance and archiving of contract files and databases
• Assist in designing and implementing policies and procedures for timely contract execution
• Identify process improvements and take corrective action
• Perform other assigned tasks

Site Contracts Manager

• Review, draft, negotiate and track legal agreements, including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments
• Review, draft and negotiate master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements and other client contracts
• Work with supervisors and internal/external stakeholders to resolve or escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update study team members on contract negotiation and execution status
• Establish, track, report and manage site contract metrics
• Support maintenance and archiving of contract files and databases
• Assist in designing and implementing procedures for timely contract execution
• Identify process improvements and take corrective action
• Work closely with Clinical Operations study teams to align deliverables with study timelines
• Perform other assigned tasks