Cognitive Research Corporation

The Senior Proposal Manager will lead, manage and execute the full life cycle of proposal development activities for Clinical Trial Proposals, budget generation, working hand in hand with Business Development. Manage and develop the process to support an efficient, high quality, and timely Proposal and contracting process. This process may include pricing, developing proposals, preparation of and revision to work orders, change orders, start-up agreements, and other contracts that support the delivery of sponsor studies. Essential Duties & Responsibilities - Lead and perform all phases of the proposal process, in partnership with Business Development, to develop compliant, compelling, and winning responses to clinical trial sponsor solicitations (RFPs, etc.) - Review clinical protocols and Request for Proposal (RFP) materials, liaise with internal teams to determine pricing and proposal strategy, and ensure compelling proposal generation for timely delivery to clients. - Centralize and standardize Requests for Information (RFI). - Collaborate with subject matter experts to manage all phases of the proposal process. - Serve as primary point of contact for all proposal related inquires, including internal stakeholders and external partners. - Contribute to establishment of payment terms on contracts and change orders with Finance and Legal as needed. - Edit, proofread, and revise proposal content for clarity, consistency, and accuracy. - Establish and manage proposal timelines, milestones, and deliverables to ensure internal and external deadlines are consistently met. - Participate in client calls, meetings, and proposal presentations as required. - Participate in quality or process improvement initiatives. - Participate in hand-over and budget review calls in accordance with submission timelines. - Work with operational leads to obtain third party vendor budgets as necessary; review third party contracts and changes in scope as they arise - Manage and mentor junior team members, including working to ensure the meeting of KPIs. - Perform other duties as assigned by management. Qualifications - Bachelor’s degree in a business or health related degree, or equivalent combination of education, training and experience; advanced degree a plus. - Minimum of 8 years of experience with proposals and contract development within life sciences, preferably within a CRO or clinical research environment. - Financial analysis experience. - Deep understanding of pricing and a working knowledge of contractual documents. - High proficiency with Microsoft Office, Word, and high skill level in Excel spreadsheets. - Effective oral and written communications with internal and external customers and at all levels of the organization. - Understand the work performed by other CRC functions and how they interact. - Strong customer relationship management and commercial acumen, and negotiation skills - Able to thrive in a fast paced, deadline drive environment while managing multiple tasks effectively. - Sound critical thinking and problem-solving skills. - Time management and ability to prioritize. - Fluent in written and spoken English. - Meticulous attention to details - Ability to travel <10%

The Clinical Project Manager (PM) supports/is responsible for the overall project coordination and management of clinical studies, including all project deliverables, from start up through close out activities. This is accomplished by ensuring all projects are completed on-time and on-budget within the scope of the client agreements. The PM is responsible for the cross-functional team’s compliance with project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable regulations. The PM is also responsible for managing study staff and across department initiatives while maintaining client satisfaction. Essential Duties and Responsibilities - Lead the initiation, planning, execution, and closeout of clinical studies, ensuring adherence to timelines, budgets, and quality standards. - Serve as a client-facing representative; coordinate and lead project meetings, develop agendas, and issue meeting minutes. - Develop and maintain core study documentation including Project Management Plans, Communication Plans, Risk Logs, timelines, and milestone trackers. - Manage study budgets, proposals, contracts, and out‑of‑scope documentation; support financial tracking and invoicing processes. - Support start‑up activities including collection of CDAs, feasibility information, budgets, and CTAs; maintain regulatory and study files. - Coordinate with functional teams to allocate resources and balance workload across the project. - Identify project risks and delays; implement contingency and risk‑control measures. - Oversee TMF management to ensure organization, accuracy, and inspection readiness. - Manage vendors and ensure their deliverables align with study requirements and quality expectations. - Support preparation of clinical reports and key study documentation. - Ensure compliance with SOPs, regulatory guidelines, and study-specific training requirements. - Perform additional project-related duties as assigned. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Minimum of 3 years relevant clinical research industry experience - Project Manager experience commensurate with years in the industry, and sufficient to successfully perform key responsibilities - Supervisory experience - Advanced knowledge of GCPs, ICH guidelines, FDA and other applicable regulations. - Intermediate knowledge of project management techniques - Proficient in Microsoft Office, Adobe and Project Management software - Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders - Ability to function independently in a fast-paced team environment - Effective verbal and writing skills; English proficiency - Ability to travel 10-20%

The Clinical Research Associate II (CRA II) is responsible for overseeing the execution of clinical trials at Investigative Sites. The Clinical Research Associate acts as a liaison between the study Sponsor, CRC and Investigative Sites. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA facilitates successful execution of studies by Investigative Sites and helps to ensure the rights, safety and welfare of human research participants as well as data integrity in clinical trials. Essential Duties and Responsibilities - Independently initiates, monitors, and closes investigational sites in accordance with FDA regulations, ICH‑GCP guidelines, study protocols, and company SOPs. - Manages assigned sites with minimal supervision, ensuring high‑quality monitoring outcomes and acceptable QA and audit readiness. - Conducts on‑site and remote monitoring visits (SIVs, IMVs, COVs) per the Clinical Monitoring Plan (CMP). - Performs comprehensive source document review (SDR) and source data verification (SDV) to ensure accuracy, completeness, and protocol compliance. - Reviews CRFs/eCRFs to identify missing, inconsistent, or erroneous data and ensures timely resolution. - Generates, tracks, and resolves data queries in collaboration with investigative sites and data management teams. - Maintains and updates study‑specific non‑CRF tracking databases and supports data collection, entry, cleaning, and reconciliation activities. - Verifies investigational product (IP) accountability, including storage conditions, dispensing, reconciliation, and shipment tracking. - Collects, reviews, and maintains essential regulatory documentation to support TMF/ISF completeness and inspection readiness. - Identifies, documents, and escalates site issues, risks, and protocol deviations, proposing mitigation strategies as appropriate. - Develops and maintains effective working relationships with Principal Investigators, study coordinators, pharmacists, and site staff. - Prepares accurate and timely monitoring visit reports, follow‑up letters, and other required study documentation. - Participates in the development and review of study protocols, CRFs/eCRFs, and monitoring tools, providing operational input. - Develops and utilizes study tracking tools, monitoring tools, and project management materials to support efficient study execution. - Serves as lead monitor for assigned studies or protocols, including organizing study files, coordinating monitoring schedules, and supporting study team meetings. - Assists with day‑to‑day study operations and collaborates cross‑functionally with minimal oversight. - Mentors and supports junior CRAs or clinical staff as assigned, including training and task oversight. - Utilizes computer and presentation skills to prepare study communications, newsletters, slide decks, and project management tools. - Travels as required to support study needs in accordance with project and monitoring requirements. - Performs other duties as assigned. Qualifications - Bachelor’s degree, or RN, in a related field or equivalent combination of education, training and experience - Minimum 2 years’ documented experience as a CRA; experience overseeing clinical trials in the pharmaceutical, hospital or CRO industry - Ability to work and travel independently with minimal supervision - Experience with numerous EDC systems - Strong knowledge of GCPs, ICH guidelines, FDA and other applicable regulations - Specialized knowledge of CNS therapeutic areas (preferred) - Proficient in Microsoft Office, Zoom and Adobe - Effective writing and verbal skills, English language proficiency - Meticulous attention to detail - Time management and ability to prioritize tasks - Ability to travel up to 70%

The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing the clinical and operational activities of assigned clinical studies. This is accomplished by ensuring all projects are completed on-time and on-budget while following all company policies, Standard Operating Procedures (SOPs) and applicable regulatory guidelines. Plan, develop, and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations. Ensure operating quality and efficiency. Essential Duties and Responsibilities - Support or lead clinical study activities from start-up through closeout, ensuring adherence to timelines, budget, quality standards, SOPs, and regulatory requirements. - Oversee development and maintenance of study documentation including informed consent forms, IRB submissions, project plans, tracking tools, financial worksheets, and regulatory files. - Engage with investigative sites during start-up to coordinate CDAs, feasibility assessments, budgets, and CTAs. - Manage and maintain the Trial Master File (TMF), ensuring accuracy, completeness, and inspection readiness. - Oversee monitoring activities, including review and approval of monitoring visit reports, tracking site issues, data queries, protocol deviations, and ensuring timely resolution. - Assign, mentor, and support CRAs; lead team training, provide performance feedback, and ensure ongoing staff compliance with required training. - Monitor enrollment trends, operational risks, and study metrics; develop mitigation strategies and escalate issues appropriately. - Conduct internal team calls, participate in Sponsor meetings, and serve as key contact for site, CRA, and Sponsor inquiries. - Coordinate clinical resource planning, monitoring schedules, and budget oversight related to monitoring activities; support PM with grant administration and invoicing. - Participate in development/testing of clinical systems and process improvement initiatives. - Perform co‑monitoring visits and, when needed, assume CRA responsibilities. - Complete vendor reconciliation and support cross-functional collaboration to ensure data quality. - May serve as a Line Manager. - May serve as Program level oversight. - Serves as Clinical representative for bid defenses. - Participates in proposal development. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Supervisory experience - Minimum 5 years’ experience in the clinical research industry - Minimum of 2 years‘ experience as a Clinical Monitor/Clinical Research Associate (CRA) strongly preferred - 2 years of Clinical Trial Management (CTM) experience, or an equivalent role to successfully perform the key responsibilities of the role. - Experience working in CNS clinical trials strongly preferred - Strong knowledge and application of clinical research process - Advanced knowledge and understanding of ICH, GCP guidelines and other regulatory rules and guidelines - Strong interpersonal and communication skills with the ability to work with all levels of management and employees, provide effective customer service, and foster positive working relationships with internal and external stakeholders - Excellent communication skills, both oral and written - Demonstrated ability to work effectively within a cross-functional team to meet objectives and deliverables; ability to be adaptable and achieve performance goals while navigating various competing demands, tight deadlines, and a fast-paced environment - Strong organizational skills that reflect the ability to manage, prioritize, and perform multiple tasks seamlessly - Strong computer skills, including proficiency in Microsoft Office, Electronic Data Capture, and other clinical systems - Meticulous attention to detail - Time management and ability to prioritize - Ability to travel 10-20%