Precision For Medicine

Manager

• Review, draft, negotiate, and track various legal agreements
• Work with Clinical Operations study team to ensure deliverables align with timelines
• Manage site contract metrics and assist in contract execution

Site Contracts Manager

Business Development Rep

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Director, Business Development – Biospecimen

Project Manager

• Plan, direct, coordinate, and deliver activities for clinical study projects
• Serve as primary point-of-contact and escalation point to the client
• Coordinate and oversee all functional services including external vendors
• Manage the study budget and ensure project remains within scope
• Develop project plans including timelines and proactive risk management
• Ensure quality management for assigned projects
• Establish tracking metrics to monitor trial progress
• Prepare project status updates and report on progress to clients

Senior Project Manager – Oncology

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines
• Establish process and procedures for overall site contract management in the organization
• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts
• Escalate and resolve complex issues with clients and internal stakeholders
• Negotiate site budget
• Provide guidance to business teams regarding operational implications of contract terms
• 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
• Coordinate execution of agreements and track agreement expirations and other obligations
• 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
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned

Senior Contracts Manager – FSP

Conversion Rate Optimizer

• Shape and refine service messaging
• Design and deliver integrated marketing campaigns
• Generate qualified leads
• Empower a growing sales team in achieving their targets
• Work closely with sales and operational stakeholders to elevate market awareness
• Strengthen our value proposition
• Accelerate lead generation across key service lines
• Develop and execute a digital content strategy
• Monitor impact of digital strategy

Senior Marketing Manager – CRO Experience Required

• 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.
• Support the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• 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, 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 a region/area.
• 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 and if applicable, GCM Managers to progress their skills so that Precision for Medicine quality standards are maintained.
• Advocate individual career development, and individual responsibility/accountability.
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.

Senior Manager, Global Clinical Monitoring

• 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
• Attends conferences, trade shows and meetings as required
• Maintains contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Business Development Director

Research Analyst

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Senior Clinical Research Associate

Medical writer

• leading the development of high-quality and on-time clinical study documents
• clinical document planning, writing, editing/formatting, and performing QC review
• develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements
• ensures smooth and effective document management from start to finish (ie, from template to final, approved version)
• ability to independently formulate key messages from clinical study data
• contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
• performing literature-based research to support writing activities

Senior Medical Writer

• The Senior Contract Manager plays a critical role in our ability to achieve our goals by creating, managing and maintaining strong relationships with business teams and establishing client and vendor contracts for those business teams.
• Responsible for contract negotiation, closeout, extension and renewal, and will communicate contractual changes and their context for the particular business to all stakeholders.
• Reviewing, drafting and negotiating all the commercial agreements between the business and their clients and vendors, including master services agreements, consulting agreements, independent contractor agreements, confidentiality agreements, work orders, change orders and other client or vendor contracts, and escalating complex issues to the corporate legal team.
• Ensuring adherence to company policies, procedures and contracting standards.
• Ensuring that the relevant leadership and business teams are apprised of the status of contract negotiations and execution.
• Coordinating execution of agreements and keeping track of expirations and other obligations.
• Assisting in the design and maintenance of contract files and databases.
• Assisting in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognizing where processes can be improved and taking initiative to improve them.
• Other tasks, as assigned.

Senior Contracts Manager

• 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, Tissue

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 (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, 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
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• 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
• review and manage collection 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 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.

Regulatory and Start-Up Specialist

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments.
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines.
• Serve as a subject matter expert within the department and company regarding site contract management.

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments.
• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts.
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• 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.
• Coordinate execution of agreements and track agreement expirations and other obligations.
• 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.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

• 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. Also provides strategic regulatory input as required
• 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

Site Contracts Manager

Director, Business Development – Biospecimen

Senior Project Manager – Oncology

Senior Contracts Manager – FSP

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Senior Manager, Global Clinical Monitoring

Business Development Director

Senior Clinical Research Associate

Senior Medical Writer

Senior Contracts Manager

Director, Business Development – Biospecimen, Tissue

Regulatory and Start-Up Specialist

Senior Contracts Manager – FSP

Senior Contracts Manager – FSP

Regulatory Manager – Senior Regulatory Manager