Precision For Medicine

Administration

• Act as key contributor in administration and support of our M365 collaboration infrastructure.
• Role requires strong hands-on experience supporting M365 services with focus on SharePoint, Teams and OneDrive administration to optimize governance while providing day-to-day support and management.
• Analysing and improving SharePoint permission structures, optimizing sites according to Microsoft modern architecture best practices, providing governance reports to management, and documenting are all expected.
• Exposure to governance solutions that would direct Microsoft's AI offerings including Microsoft 365 Copilot and Copilot Studio.
• PowerShell scripting for efficient tenant administration.
• Responsible for capacity planning and lifecycle management of SharePoint environment leveraging ShareGate, AvePoint, and other 3rd party offerings where possible.
• Work closely with help desk technicians for resolutions to escalated tickets and training on new features.
• Work closely with security operations to maintain proper security posture. Focus on security requirements when designing a solution.
• Migrating workloads end-to-end from on-premise to cloud or cloud to cloud using ShareGate.
• Reporting on cloud licensing and resource utilization in order to preserve costs a plus

SharePoint Administrator

• Act as key contributor in administration and support of our M365 collaboration infrastructure. Role requires strong hands-on experience supporting M365 services with focus on SharePoint, Teams and OneDrive administration to optimize governance while providing day-to-day support and management.
• Analysing and improving SharePoint permission structures, optimizing sites according to Microsoft modern architecture best practices, providing governance reports to management, and documenting are all expected.
• Exposure to governance solutions that would direct Microsoft's AI offerings including Microsoft 365 Copilot and Copilot Studio.
• PowerShell scripting for efficient tenant administration.
• Responsible for capacity planning and lifecycle management of SharePoint environment leveraging ShareGate, AvePoint, and other 3rd party offerings where possible.
• Work closely with help desk technicians for resolutions to escalated tickets and training on new features.
• Work closely with security operations to maintain proper security posture. Focus on security requirements when designing a solution.
• Migrating workloads end-to-end from on-premise to cloud or cloud to cloud using ShareGate.
• Reporting on cloud licensing and resource utilization in order to preserve costs a plus.

• Administration and support of the company’s SharePoint online environment
• Analyze and improve SharePoint permission structures
• Providing governance reports to management
• PowerShell scripting for efficient tenant administration
• Migrating workloads end-to-end from on-premise to cloud

• Responsible for the administration of the company’s SharePoint online environment
• Act as key contributor in administration and support of M365 collaboration infrastructure
• Analyzing and improving SharePoint permission structures
• Providing governance reports to management, and documenting expectations
• PowerShell scripting for efficient tenant administration
• Responsible for capacity planning and lifecycle management of SharePoint environment
• Work closely with help desk technicians for resolutions to escalated tickets
• Work closely with security operations to maintain proper security posture

Clinical Research

• Own the planning, execution, and oversight of clinical studies
• Serve as the primary client contact and ensure delivery in compliance with protocol, SOPs, ICH-GCP, and regulatory requirements
• Shape country-level recruitment strategies
• Lead feasibility and site start-up
• Guide monitoring and quality strategies
• Mentor CRAs and partners as the regional team scales
• Develop study related clinical documents
• Identify and develop training needs for CRAs and third-party vendors
• Generate potential site list from key stakeholders
• Identify potential risks to the enrollment targets based on feasibility analysis
• Develop and finalize the country recruitment/retention strategy
• Develop timely and effective communication with investigators and study team
• Lead internal clinical team meetings and set expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintain FAQ log
• Support planning and conducting investigator meetings
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Generate and utilize metric reporting to ensure study timelines.

Clinical Trial Manager, Senior

Business Development Rep

• The Account Development Representative II is responsible for the identification, information gathering, planning and coordinating of sales-based communication activities for a selection of designated accounts and contacts to effectively support business growth.
• Ultimately sourcing new sales opportunities for the Business Development team through inbound lead qualification and outbound prospecting inclusive of Clinical Solutions, Labs and Biospecimens.
• Periodically liaises directly with the Business Development team to identify specific companies of interest for continued nurtured outreach and meeting/RFP provision.
• Analyzes competitive environment to help make recommendations
• Develops an annual outreach plan (reviewed monthly with LM and Business Development team) focused on securing new and repeat business from current and prospective biotech and pharmaceutical companies based on the analysis of:
• Social media (business news review, financial news, new lead identification, …)
• Competitive intelligence / business strategy (reviewing competitors’ website, conferences, communication/marketing activities)
• Decision makers and influencers within the identified company
• Undertakes research and analysis of Precision’s markets, competition, product mix, and specified product markets
• Works closely with the Marketing teams to coordinate appropriate collateral provision to support the sales efforts of the company
• Responsible for updating appropriate systems (Customer Relationship Management, Sales Enablement platforms etc.) in a timely manner to ensure high standards of data integrity and for generating accurate weekly/monthly activity reports
• Provides regular feedback to the LM, and Business Development leadership on the positioning of the company regarding pricing, competitiveness, and market conditions

Account Development Representative II

Medical Director

• Serve as the project physician and provide medical and scientific expertise to project teams
• Ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety
• Participate in the strategic planning and execution of critical development programs for a variety of clients in oncology or autoimmune disease
• Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings
• Write or edit scientific content of deliverables within budget and timelines
• Collaborate with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy
• Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts)
• Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications
• Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed
• Serve as a medical resource for study sites, the project team and clients
• Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions
• Assume responsibility for medical and safety monitoring on assigned projects
• Participate in feasibility discussions relating to specific project proposals
• Develop training modules and provide training concentrating on disease states
• Participate in process improvement activities
• Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally

Vice President

• Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy.
• Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings.
• Provides strategic drug development consulting to autoimmune, or oncology depending on specialty, and rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights.
• Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications.
• Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed.
• Participate and drive feasibility discussions relating to specific project proposals.
• Develop training modules and conducts training for project teams and colleagues as necessary.
• Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct.
• Propose strategies to manage and accelerate timelines for drug development strategies.
• Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients.

Vice President, Clinical Development

Manager

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
• Ensure adherence to company policies, procedures and contracting standards
• Update relevant study team members regarding the status of contract negotiations and execution
• Establish, track, report and manage site contract metrics
• Support the maintenance of contract files and databases, including contract archiving
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts
• Recognize where processes can be improved and take corrective action

Contracts Manager

Compliance

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings

Regulatory Manager – Clinical Trials

Project Manager

• independently lead clinical projects in accordance with the study budget and scope of work
• use strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives
• serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• liaise with Project Team and senior management of both Precision and sponsors, including C level
• handle and lead all aspects of a clinical research trial or trials
• total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

Senior Project Manager – Clinical Trials

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Other tasks as assigned.

Site Contracts Manager

• Manages and provides leadership to Directors, drives strategy to plan, coordinate, and deliver all activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.
• Work with Senior Leadership to support defined corporate and departmental business strategies for Precision
• Direct, manage and ensure collaboration within a team of Directors, Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform
• Provide leadership and oversight on all programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design)
• Interact with study sponsors as primary point of escalation beyond project management
• Optimize the profitability of the Project Management organization to meet or exceed budget targets
• Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
• Select, train, develop and manage the performance of talent in project leadership positions (Directors, Project Directors and Project Managers)
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers
• Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
• Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance
• Understand and manage project/program inter-dependencies to achieve program milestones/deliverables
• Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
• Measure and report KPIs and lead continuous improvement
• Recognize, exemplify and adhere to Precision’s values that center on our commitment to quality, our people, clients and performance
• May function as Executive Oversight for projects not assigned as DPM • Manages workload of supervised staff with continued assessment and adjustment as needed
• Provides on-going feedback, development and coaching of Directors, Project Directors and Project Managers including annual performance reviews

Executive Director, Project Management

QA Engineer

• The Director of Quality Assurance (QA) Systems is responsible for ensuring the validation, integrity, and compliance of systems across Precision for Medicine (PFM)
• Oversees the development, implementation, and maintenance of QA strategies and processes that support regulatory requirements, industry standards, and internal policies
• Leads cross-functional teams to ensure systems are validated, documented, and maintained in a state of control
• Manage risk-based Computer System Validation planning and execution, aligned to regulatory guidelines
• Establish and enforce QA policies and procedures for PFM systems
• Input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies
• Serve as the primary liaison with regulatory agencies and third parties for system-related audits and inspections

Director, Quality Assurance – Systems

Payroll

• Co-ordinate and process monthly payroll across multiple European counties, liaising with the 3rd party payroll providers to ensure the correct information is processed in respect of starters, leavers, and changes.
• Review and verify payroll data, including earnings and deductions.
• Prepare and submit payroll reports to internal and external stakeholders.
• Employee support- serve as a point of contact for payroll related inquiries.
• Conduct system audits and reconciliation to identify any discrepancies in payroll data and calculations.

SharePoint Administrator

SharePoint Administrator

SharePoint Administrator

SharePoint Administrator

Clinical Trial Manager, Senior

Account Development Representative II

Medical Director

Vice President, Clinical Development

Contracts Manager

Regulatory Manager – Clinical Trials

Senior Project Manager – Clinical Trials

Site Contracts Manager

Executive Director, Project Management

Director, Quality Assurance – Systems

Payroll Specialist