CTI Clinical Trial and Consulting Services

Medical Director

• Drive growth of a therapeutic area portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials
• Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery
• Accountable for medical oversight and management of awarded studies, including protocol review, eligibility discussions, oversight of medical issues, training of internal and site teams, safety review, and medical support of regulatory issues
• Early engagement business development activities, including providing advice and recommendations on protocols and clinical development plans, assessing key needs of sponsors, and applying innovations
• Responsible for working with a broad range of sponsors, creatively assessing opportunities, and developing strategies for trials and innovations for the execution of studies
• Use clinical, scientific, and operational knowledge to harness data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for clinical development projects, studies, and trials, addressing the specific needs and challenges of each customer
• Provide clinical and scientific expertise to all CTI departments as requested and collaborate closely with teams to develop integrated strategies for clinical trials and studies
• Partner with the regulatory team on clinical development plans, target product profiles, regulatory submissions, interactions with health authorities, and protocol development
• In partnership with Sales, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets
• Along with other key experts, responsible for leading teams in developing focused proposals
• Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, understanding the standard of care and competitive landscape, informing strategies for site and country selection and patient recruitment
• Support preparation of customer and bid defense meetings, e.g., training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys therapeutic area strategy
• Attends and presents at customer meeting, or bid defense or partnership meetings, as required
• Responsible for staying current on industry pipeline and scientific and business landscape; does due diligence research of the therapeutic landscape; educates and informs CTI clinical and business teams about cutting-edge therapeutic developments
• Drive thought leadership activities including presentations, publications, and interactions with the medical scientific community to connect key areas of growth and innovation that CTI is focused on. which include cell and gene therapy and rare disease, and groundbreaking strategies to optimize the execution of clinical trials, using data and patient-centered approaches
• Administration and management of the Medical Affairs department, including direct reports, review of finances, and shaping the vision and strategy for the medical department

Medical Director – Cardiology

Software Engineer

• Support the design, development, and validation of clinical trial databases
• Build and test study databases using platforms such as Medidata Rave or OmniComm TrialMaster
• Program validation checks and ensure data structures align with approved CRFs and study specifications
• Perform comprehensive user acceptance testing and support data cleaning through query management
• Maintain complete documentation in accordance with SOPs

Clinical Programmer

• Drive growth of a therapeutic area portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials
• Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery
• Accountable for medical oversight and management of awarded studies, including protocol review, eligibility discussions, oversight of medical issues, training of internal and site teams, safety review, and medical support of regulatory issues
• Early engagement business development activities, including providing advice and recommendations on protocols and clinical development plans, assessing key needs of sponsors, and applying innovations
• Responsible for working with a broad range of sponsors, creatively assessing opportunities, and developing strategies for trials and innovations for the execution of studies
• Use clinical, scientific, and operational knowledge to harness data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for clinical development projects, studies, and trials, addressing the specific needs and challenges of each customer
• Provide clinical and scientific expertise to all CTI departments as requested and collaborate closely with teams to develop integrated strategies for clinical trials and studies
• Partner with the regulatory team on clinical development plans, target product profiles, regulatory submissions, interactions with health authorities, and protocol development
• In partnership with Sales, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Along with other key experts, responsible for leading teams in developing focused proposals
• Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, understanding the standard of care and competitive landscape, informing strategies for site and country selection and patient recruitment
• Support preparation of customer and bid defense meetings, e.g., training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys therapeutic area strategy
• Attends and presents at customer meeting, or bid defense or partnership meetings, as required
• Responsible for staying current on industry pipeline and scientific and business landscape; does due diligence research of the therapeutic landscape; educates and informs CTI clinical and business teams about cutting-edge therapeutic developments
• Drive thought leadership activities including presentations, publications, and interactions with the medical scientific community to connect key areas of growth and innovation that CTI is focused on. which include cell and gene therapy and rare disease, and groundbreaking strategies to optimize the execution of clinical trials, using data and patient-centered approaches
• Administration and management of the Medical Affairs department, including direct reports, review of finances, and shaping the vision and strategy for the medical department

Executive Medical Director

Clinical Operations

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead
• Set goals, and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
• Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities
• Implement project activities according to scope of contracted work
• Evaluate and manage project budget against project milestones and scope and collaborate with the trial assigned Director as needed to take corrective measures where necessary to keep project in line with budget
• Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins
• Prepare or provide oversight and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to provide effective solutions to challenges that arise during the clinical trial project
• Serve as client contact at project operational level
• Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations
• Provide oversight and management of third-party vendors’ financial spend
• Closely reviews and assesses trial’s KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges
• Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management
• Ensure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol
• Lead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes
• Prepare or provide oversight/approval of project status reports for assigned projects

Clinical Project Manager III – Senior

Project Manager

• Leadership Role for CTI RWE Project Management team with responsibilities to include: business development, client interactions, developing project management strategies and planning for clients, participating in and overseeing RWE studies and leading and managing project management personnel.
• Interacts with clients to determine study implementation strategies, design and operational conduct, when applicable.
• Applies strategic thinking skills to the requirements for operational conduct with clients and other study team stakeholders.
• Collaborates with RWE leadership and Research Scientists on strategic planning and implementing RWE projects/studies.
• Ensures the project team proactively identifies potential study risks and implements mitigation strategies, as appropriate.
• Assists in developing proposals, including scientific rationale, methodology, timelines, and budgets.
• Attends and/or leads bid defense presentations in collaboration with business development.
• Responsible for financial management and tracking of all projects from the North American region.
• Oversees North American revenue recognition and revenue projections with project management staff.
• Oversees study budgets, in collaboration with the project manager, to ensure work aligns with the budget and potential out-of-scope activities are proactively identified and discussed with study sponsors.
• Manages Project Management team members, including administrative, development and adherence to Standard Operating Procedures (SOPs), and career development training and mentoring.
• Manages and develops partnerships with study sponsors and strategic partners and vendors, such as clinical assessment licensing companies, EDC/DCT partners, data asset vendors, and internal and external stakeholders.
• Develops and maintains knowledge of internal databases, warehouses, business intelligence (BI) systems, and data analysis tools, as appropriate to role.
• Collaborates with various CTI departments and team members.
• Identifies and conducts training for programs and staff as needed.

Director, Project Management – Real World Evidence, Late Phase

Business Development Rep

• Responsible for selling CTI global central and bioanalytical laboratory services.
• Identify, contact and cultivate new clients and serve as client manager for existing clients.
• Secure and maintain relationships with qualified targets and decision makers within biotech and pharma.
• Collaborate with CTI’s proposal team to deliver budgets and proposals.
• Develop and maintain excellent working relationships with laboratory operational management and proposal/contracting teams.
• Attend therapeutically focused conferences as a representative of CTI.
• Lead and participate in capabilities discussions and communicate with existing accounts to ensure needs of accounts are being met.

Manager/Director, Business Development & Client Management, Lab Services

Sales

• Secure and maintain relationships with qualified targets and decision makers within biotech and pharma, uncovering potential sales opportunities and developing effective sales strategies
• Proactively engage with targeted business development accounts to explain CTI offerings that align with customer's needs
• Identify and initiate early discussions with clients specific to CTI’s RWE areas of focus and growth
• Work in collaboration with CTI's proposal team to deliver budgets and proposals
• Develop and maintain excellent working relationships with key members of CTI's RWE operational management and proposal/contracting teams
• Develop and implement specific RWE strategies to drive awareness, lead generation and opportunity identification
• Attend conferences as a representative of CTI and meet with prospective clients also in attendance
• Lead and participate in capabilities discussions and bid defense meetings
• Communicate with existing accounts and internal CTI representatives to ensure needs of accounts are being met
• Present sales opportunities to management and work with internal departments/team members to close complex sales
• Monitor and update status of leads to ensure pipeline is maintained
• Communicate all account activity to sales leaders/CTI executives and maintain updates in CTI's CRM system
• Manage sales departmental metrics

Director, Real World Evidence BD Sales

Data Scientist

• Serve as the primary CTI Clinical Data Management (CDM) contact with sponsors
• Represent the DM group on CTI project teams
• Responsible for study-specific CDM document development and maintenance
• Manage the data cleaning process from start-up through data archival
• Develop and/or approve project database builds, testing, and validation
• Coordinate receipt and processing of information for projects

Clinical Data Manager

• Plan, implement, facilitate and evaluate the full execution of assigned clinical trials
• Oversee management of multiple clinical trials from the planning phase to the analysis phase
• Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines
• Take corrective action where necessary
• Ensure training of assigned project teams
• Provide supervision, guidance and mentoring to CPMs

Director, Clinical Project Management – Level Dependent on Experience

• Secure and maintain relationships with qualified targets and decision makers within biotech and pharma, uncovering potential sales opportunities and developing effective sales strategies
• Work with targeted business development accounts to secure future business - explain, offerings and align CTI offerings to meet customer’s needs
• Work in collaboration with CTI’s proposal team to deliver budgets and proposals, including providing key direction on proposal text and budget scope.
• Develop and maintain excellent working relationships with key members of CTI’s clinical operational management and proposal/contracting teams
• Develop and implement specific disease strategies to drive awareness, lead generation and opportunity identification
• Attend therapeutically focused conferences as a representative of CTI and meet with prospective clients also in attendance
• Lead and participate in bid defense meetings, including leading the preparations, strategies, and follow-up efforts
• Lead and participate in capabilities discussions, including leading the presentation, strategies, and follow-up efforts
• Communicate with existing accounts and internal CTI representatives to ensure needs of accounts are being met
• Present sales opportunities to management and work with internal departments/team members to close complex sales
• Continuously monitor and update status of leads to ensure pipeline is maintained
• Communicate all account activity to sales leaders/CTI executives and maintain updates in CTI’s CRM system
• Manage sales departmental metrics

Director, Business Development – Client Management

Research Analyst

• Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies
• Conduct site visits and complete site visit deliverables with quality and within timelines
• Assist with study start-up activities, including feasibility, pre-study activities, and site selection
• Participate in investigator, client, and project team meetings
• Manage ISF and TMF for all assigned study sites in accordance with SOPs

Senior Clinical Research Associate

• Serve as main CTI contact for assigned study sites
• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV])
• Assist with or oversee study start-up activities
• Collect, review and track essential/regulatory documents
• Participate in investigator, client and project team meetings
• Create and implement subject enrollment strategies for assigned study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team

Clinical Research Associate II – Senior Clinical Research

• Responsible for overseeing the activities of the EMEA BD Sales Team
• Responsible for Selling CTI Clinical Trials, Regulatory/Scientific Affairs and Real World Evidence
• Recruit and hire BD Sales Team members
• Assist in establishing individual sales targets for the team members and the overall EMEA Yearly Sales Target
• Ensure the Sales Team is appropriately targeting prospective clients
• Schedule and attend weekly meetings with each member of the BD Sales Team in order to remain aware of sales activities and future opportunities
• Attend client meetings with the BD Team and give direction and feedback on performance
• Attend conferences and medical meetings as required to observe the Team’s performance
• Participate in regular meetings with the Sales Team as well as with Executive Management and provide strategic insights toward achieving our corporate sales goals
• Responsible for ensuring the EMEA BD Sales Team implements the tactical plans for the region
• Organize quarterly BD Sales Team meetings
• Lead presentations to the BD Sales Team
• Develop a general knowledge base of CTI experience in different therapeutic areas
• Monitor monthly time and activity versus productivity of the BD Sales Team to assess and implement continuous improvement
• Assist in assessing new RFP’s from the NA Region
• Identify training needs of the Sales Team members and assist with implementing training programs
• Provide status reports

Executive Director – Business Development, Client Management

• Plan, implement, evaluate, and complete execution of assigned laboratory clinical trials/projects; may function as a global lead, where applicable.
• Expected to manage medium to high complexity trials.
• Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned laboratory clinical trials/projects
• Provide oversight and coordination of the operational aspects of the functional areas on assigned clinical trials/projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and laboratory procedures
• Provide management of the full scope of laboratory clinical trials/projects including global clinical trials/projects from start-up through closeout; provide oversight of functionally assigned teams members on laboratory clinical trials/projects; manage multiple clinical trials/projects simultaneously
• Work closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projects
• Provide coordination of a laboratory clinical trial/project including organization, implementation, and management of scoped activities
• Prepare or provide oversight to the development of project plans and timelines; work with laboratory leadership and/or line manager to provide effective solutions to challenges that arise during the laboratory clinical trial/project
• Participate in or provide oversight and guidance in the development of clinical trial/project required deliverables
• Serve as Global Project Manager and/or client contact at clinical trial/project operational level
• Provide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations
• Provide oversight of appropriate clinical trial/project tracking using computer-assisted programs and ensure timely entry of project information by all project team members to enable accurate reporting to clients and CTI executive management
• Monitor ongoing resource needs to the clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issues
• Ensure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/project
• In conjunction with the client and cross-functional CTI laboratory departments, create the Laboratory Specifications Plan based upon contracted services at the initiation of a new clinical trial/project, and maintain and update the document as needed throughout the lifecycle of the clinical trial/project
• Build clinical trial/project-specific laboratory database in lab information management system (LIMS) at initiation of a new clinical trial/project; maintain and update the database as needed throughout the lifecycle of the clinical trial/project.
• Develop project-specific site tools such as the Laboratory Manual and Quick Reference Guides (if applicable); maintain and update these documents as applicable throughout the lifecycle of the clinical trial/project
• Work with cross-functional CTI laboratory departments to design clinical trial/project-specific tools and supplies such as sample requisition forms, sample labels, and lab kits
• Serve as liaison between logistics and data management to resolve issues with samples
• Implement project activities according to scope of contracted work
• Coordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the client
• Evaluate and manage clinical trial/project budget against project milestones and scope; work with laboratory leadership to take corrective measures where necessary to keep clinical trial/project in line with budget
• Assess scope of work against client contractual agreements and works with laboratory leadership to facilitate change of scope orders when appropriate
• Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes
• Prepare or provide oversight/approval of weekly and/or monthly clinical trial/project status reports for assigned projects
• Participate and contribute to site training meetings, such as Investigator meetings or site initiation visits
• Suggest and participate in process improvement activities and initiatives

Project Manager, Laboratory Services

• Oversee and manage RWE clinical studies and other clinical projects
• Manage multi-functional study teams throughout the study or project from kick-off through close-out
• Ensure all functional areas study team members deliver in a timely manner, on budget and with high quality throughout the duration of the study
• Assist in study resourcing needs with other functional areas, when needed
• Develop timelines, trackers, project management plans and provide oversight for key functional plans
• Monitor for potential issues and risks throughout the study
• Prepare or oversee development, review, and finalization of deliverables for clients and senior management