ProPharma

Project Manager

• Provide guidance and support as a project leader on a cross functional basis within the Regulatory Affairs CTA group
• Work effectively with various stakeholders to ensure each projects success
• Lead the preparation, review and submit regulatory clinical trial applications within the EU
• Ensure all submission activities meet key regulations within the region
• Ensure compliance is achieved to the EU CTR regulations throughout each project
• Implement and submit key documentation on to our clients systems
• Provide key project leadership across a range of groups
• Ensure all timelines and milestones are achieved throughout the project
• Overall support our client with strategic and operational goals within the Regulatory Affairs CTA space

Freelance Regulatory Affairs Project Manager – Clinical Trial Applications

Clinical Operations

• Ensure patients within the trials follow all protocols set out (dosed)
• Full management of the CRO partners throughout the project
• Effective coordination on a cross-functional basis which includes Regulatory, Quality, Supply Chain etc.
• Ensure compliance throughout the project to all necessary guidelines
• Manage key stakeholders throughout the project
• Able to consider all avenues affecting the success of the project and devise solutions to any bottlenecks found
• Ensure the overall success of the project as a key project leader

Freelance/Contract Clinical Project Manager

Solutions Engineer

• Architect, design, and provide solutions for data-intensive applications in hybrid cloud environments
• Leverage AWS Cloud Services for scalable solutions
• Develop scalable, efficient data management frameworks
• Collaborate with business stakeholders, portfolio architects, and IT teams
• Establish and enforce data standards, procedures, and definitions for data governance and quality assurance

AWS Certified Solutions Architect, Consultant

Backend Engineer

• Leverage your expertise across frontend, backend, databases to optimize our systems and build complex features as part of the team.
• Take ownership of end-to-end feature development, making technical decisions that ensure our platforms are scalable, performant, and maintainable across the entire stack.
• Support and debug critical production issues, and implement sophisticated solutions while carefully considering business impact.
• Provide leadership mentorship to less experienced team members, helping establish best practices and guiding architectural decisions while fostering a collaborative learning environment.
• Embrace new languages and frameworks, containers and cloud.
• Collaborate with other teams, technical and business/product leadership to ensure best quality of the product that delights the users.
• Establish data product patterns (ownership, versioning, schemas, discoverability, SLAs, contracts, and APIs).

Data Engineer, Clinical Data Products – AWS, Python, Veeva

QA Engineer

• Develop quality system for CMC Quality Management
• Quality management of contract manufacturing organizations (CMOs)
• QA oversight of CMOs which includes periodic audits of CMOs and testing laboratories
• Establish and manage quality agreements
• Oversee quality processes relevant to outsourced activities
• Conduct quality risk assessments of CMOs
• Review and approve all quality records generated by CMOs
• Leadership as QA Head
• Train internal staff on CMO quality oversight practices

Freelance/Contract QA CMC Consultant – Director Level

Medical Director

• Oversees the management of medical monitoring during clinical trials and projects.
• Acts as liaison for investigators and monitors regarding study-related medical/safety issues.
• Provides and/or oversees medical review of key clinical documents and regulatory documents.
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols.
• May present topline results to Sponsors or Competent Authorities.
• Trains project team on therapeutic indication and/or treatment modality.
• Oversees, reviews, and directs medical and safety sections of regulatory document submissions.
• Assists with RFI/RFP completion and contributes medical/scientific expertise to proposal development.
• Actively participates in early client engagement calls.

Research Analyst

• Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies
• Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships
• Serve as a point of contact for investigators and site staff
• Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates
• Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
• Conduct thorough site qualifications visits
• Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams
• Conduct efficient and comprehensive site initiation visits
• Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements
• Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs
• Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies
• Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements)
• Ensure all clinical site staff actively participating in the study are appropriately trained
• Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team
• Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team
• Assist clinical site in resolving issues, if appropriate
• Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.)
• Communicate status of Site management activities on a routine basis to the Clinical Project team and management
• Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members
• Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study
• Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members
• Communicate project specific information to/from trial sites through teleconferences, newsletters, etc.
• Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis
• Document monitoring activities in monitoring visit reports and follow-up letters
• Communicate serious issues to appropriate parties, in a timely manner
• Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
• Participate in Investigator Meetings, and other study trainings and meetings as required
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Support and comply with the company’s Quality Management System policies and procedures
• Maintain regular and reliable attendance
• Ability to act with an inclusion mindset and model these behaviors for the organization
• Ability to work designated schedule
• Ability to work nights and/or weekends, as needed
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
• Ability to work on a computer and phone simultaneously
• Ability to use a telephone through a headset
• Ability to travel 50% of working time away from work location may include overnight/weekend travel

Clinical Research Associate – West Coast

• Provide operational support to QA activities linked to the complaint process for one global life-sciences client
• Support returns processing, temperature excursion evaluation, alert handling and related tasks
• Support and lead deviation management as and when directed
• Support other QMS tasks for clients based within the EU
• Work towards expanding skills and aim at becoming a Responsible Person or Qualified Person
• Initially support a single product complaint management project on a 1-year fixed term contract, with likely transition to permanent role

Compliance and Quality Assurance Consultant

• Oversight and conduct of clinical research trials ensuring compliance with applicable regulations
• Ensure quality of clinical data meets requirements for Regulatory Authority approval
• Strategic and tactical operational planning and execution of all phases of clinical programs
• Partner with internal functions to develop clinical study plans, including timelines and budgets
• Prepare or facilitate preparation of essential study documentation (protocols, CRFs, informed consent forms, feasibility assessments)
• Lead and actively participate in cross-functional team meetings
• Support site activities: site identification, investigator meetings, site training, research agreements, and study budget negotiations
• Oversee or conduct study monitoring: develop monitoring plans, manage resources, perform initiation/interim/closeout visits and activities
• Perform or oversee study closeout procedures, product disposition, and prepare sites for audits
• Develop and maintain tracking systems for study management