Precision Medicine Group

Compliance

• 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 for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines.
• 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.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities.
• 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 for site review and management of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.
• Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans.

Regulatory and Site Start-Up Specialist

Conversion Rate Optimizer

• Shape and refine service messaging.
• Design and deliver integrated marketing campaigns.
• Generate qualified leads and empower a growing sales team in achieving their targets.
• Work closely with sales and operational stakeholders to elevate market awareness, strengthen value propositions, and accelerate lead generation across key service lines.

Senior Marketing Manager – CRO Experience Required

Manager

• The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality.
• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.

Manager, Global Clinical Monitoring

• Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth.
• Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up.
• Support to negotiations of contracts when needed and to deal with key FSP clients.
• Participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters.
• Line manages a Team of FSP contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work.
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure.
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function.
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards.
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor.
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the FSP portfolio level.
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables.
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings.

Line Manager, Site Contracts Management

• Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth.
• Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time.
• Play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up.
• Support to negotiations of contracts when needed and to deal with key FSP clients.
• Participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership.

• Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth.
• Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up.
• Support to negotiations of contracts when needed and deal with key FSP clients.
• Participate in corporate strategic initiatives for the Start Up group, such as FSP business development and be part of the SSU Leadership.

• Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth
• Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up
• Support to negotiations of contracts when needed and to deal with key FSP clients
• Participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership
• Acts as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings

Line Manager – Site Contracts Management

• Manage, oversee and support Precision’s FSP Contract Management Team as well as FSP Site Contracts business development and growth
• Work closely with any stakeholders to ensure FSP Site Contracts Team has all needed tools to deliver Site Contracts in the shortest possible time
• Play a key role to ensure all other deliverables of the FSP Site Contracts Team are in alignment with defined FSP set-up
• Support to negotiations of contracts when needed and deal with key FSP clients
• Participate in corporate strategic initiatives for the Start Up group, such as FSP business development and will be part of the SSU Leadership
• Act as a single point of contact for FSP Clients and Precision FSP Team and stakeholders in connection with any FSP site contracting matters
• Line manages a Team of FSP contract and budget associates
• Allocate resources for new business in the organization, forecasting and planning current and expected FSP work
• Participate in discussions on resources needs and plan for the future on FSP contract’s structure
• Report and manage FSP contract metrics including productivity of the FSP site contract’s function
• Ensure adherence to applicable company and Sponsor policies, procedures, and contracting standards
• Escalate and resolve complex issues with Precision’s and Sponsor’s Legal, Finance or supervisor
• Support the review, drafting, and negotiations of a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements
• Oversee execution of agreements at the FSP portfolio level
• Recognize where processes can be improved and take corrective action
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts and FSP business deliverables
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings

• The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals.
• Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce.
• Requires the ability to independently lead, manage, and motivate a team of CRAs and if applicable GCM Managers.
• Ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful.
• Provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction.
• Generate action plans and provide developmental/strategic oversight to optimize CRA services.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project.
• Collaborate with the Clinical Team Leads and Clinical Operations Management Team to ensure resource needs are met appropriately.

Senior Manager, Global Clinical Monitoring

Business Development Rep

• Identifies opportunities for Biospecimen products and services, with an emphasis on biofluids, prospective collections, tissues, cells and other specialty- and central-lab service offerings
• Builds and maintains relationship and organization map for assigned and identified new Key Clients
• Retain and grow existing account base through the identification of new opportunities and exploring potential cross selling across the Precision Translational Sciences portfolio
• Follow up on all marketing leads and website inquiries to qualify leads
• Prospects for new clients, as appropriate, within the given geographic market to ensure a robust pipeline of opportunities
• Identify potential clients and decision makers within the client organization, perform needs analysis, identify opportunity, and follow up with potential customers
• Ensure that any client complaints are forwarded to the appropriate individual(s) and ultimately resolved in a prompt and professional manner
• Closes new business and expands existing business relationships
• Connects SME’s and other BD’s where added value to client is available
• Establishes a strong working relationship with marketing, clinical operations, lab operations, project management, and other internal stakeholders
• Qualifies & enriches in-bound leads
• Closes business and organically develops future – recurring business
• Attend conferences, trade shows and meetings as required
• Maintain clean customer relationship management metrics in Salesforce.com and other CRM systems
• Other responsibilities as assigned

Director, Business Development – Biospecimen

Director

• Serve as the primary client liaison and strategic advisor for all Data Solutions accelerator and ARD engagements.
• Manage day-to-day client communication on strategy, planning, and delivery, functioning as an extension of the client’s team.
• Oversee the flawless execution of multiple accelerators and ARD deployments across various engagement models.
• Manage and optimize onsite-offshore delivery operations, ensuring tight, friction-free coordination with India-based technical and content teams.
• Act as a dedicated “leader-coach” to 2–4 direct reports (North America-based Engagement Managers).

Senior Engagement Director, Data Solutions

Full-stack Engineer

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Software Engineer II

• The candidate will be responsible for the configuration and delivery of client-facing applications.
• The candidate may assist with support for the development of process enhancements under the guidance of the Sr. Software Engineer and the Manager, Technical Operations.
• Responsibilities will also include day-to-day maintenance of the health care application systems in operation, including tasks related to identifying and troubleshooting application issues and issues resolution or escalation, root cause analysis, manage communication and client relationship management in partnership with Infrastructure Service Support team members.
• Configure client-facing applications exactly as per requirements gathered by engagement teams and follow the Medical, Legal, Regulatory (MLR) guidelines in this process.
• Update client-facing applications exactly as per requirements gathered by engagement teams and follow the Medical, Legal, Regulatory (MLR) guidelines in this process.
• Represents the Application Operations / Development team on all active projects.
• Participates in the daily application operations / development stand-up meetings.
• Follows established procedures for change management across applications where changes are necessary.
• Documents and maintains the application operations / development standard operating procedures.
• Creates WIKI articles for common processes that are repeated and can be shared with others.
• Coordinate with Application Development Team to successfully deploy software releases in both User Acceptance Testing and Production environments.
• Setup environments for all new implementations.
• Configure Single Sign On integrations for client builds.
• Support the development of product unit tests that will be used for future application regression testing.
• Measures application development key performance indicators, for example: bug density, sprint analysis, test coverage, etc.
• Work with the Product Team to implement new application enhancements and features.
• Ensures all application changes are made in accordance with life-cycle methodology and risk guidelines.
• Interact with end users, internal users, development vendors, data analysts, and other engagement team members.

Software Engineer I

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Business Development Director

Operations

• Lead the planning, execution, and delivery of enterprise initiatives and cross-functional programs from initiation through close-out.
• Define project scope, objectives, deliverables, timelines, and success metrics in alignment with organizational priorities.
• Manage project risks, dependencies, and issues, escalating as appropriate to ensure successful outcomes.
• Apply structured project and program management methodologies to ensure consistent, predictable delivery
• Support the vision of and commitment to continuous improvement in operational excellence across all activities.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation.
• Lead stakeholders in root-cause problem-solving techniques to identify core process challenges.
• Lead the development of recommendations for process improvement, leveraging subject matter experts for critical input.
• Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
• Identify, develop and execute strategies for on-going and sustained improvement in operational functions, including identification of tools, systems, staffing or other resources, procedures, and communication.
• Partner on the design and implementation of new business processes with organizational context and priorities in mind.
• Lead organizational change management to ensure adoption and sustainability of process changes.
• Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion.
• Identify operational risks and lead implementation of mitigation plans.
• Ensure or lead the documentation of business process.
• Establish key performance metrics and dashboards for monitoring operational performance.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Oversee or lead training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives.
• Standardizes best practices and processes across the organization to ensure consistency and sustainability.
• Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
• Develop and monitor key performance indicators (KPIs) to track progress and drive decision-making.
• Monitor adoption of process, system and organizational changes to ensure long-term and sustained adoption.

Regulatory and Site Start-Up Specialist

Senior Marketing Manager – CRO Experience Required

Manager, Global Clinical Monitoring

Line Manager, Site Contracts Management

Line Manager, Site Contracts Management

Line Manager, Site Contracts Management

Line Manager – Site Contracts Management

Line Manager, Site Contracts Management

Senior Manager, Global Clinical Monitoring

Director, Business Development – Biospecimen

Senior Engagement Director, Data Solutions

Software Engineer II

Software Engineer I

Business Development Director

Associate Director – Operational Excellence