Role Summary

We are seeking an Associator Director, Monitoring Oversight Management, to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials.  This role will also support contract Oversight CRAs globally.  In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical.  This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Key Responsibilities

In-house responsibilities

• The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• Responsible for hiring in-house Oversight CRAs
• Assist with creation, review and revision of departmental SOPs and policies, as applicable
• Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Assist with creation and delivery of department initiatives, improvement plans and/or training
• Create SOPs and process to support the responsibilities of the monitoring excellence organization
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Contribute to development and implementation of risk-based monitoring strategies
• Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas
• Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas
• Facilitate resolution of region specific and site management related challenges
• Communication and issue resolution with clinical vendors, as needed
• Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Periodic review of monitoring visit reports and metrics, as applicable
• Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports

Field management responsibilities

• Conduct periodic quality visits for Senior Oversight CRAs, as needed
• Ensure all site oversight visits are completed within the expected timelines globally
• Oversee all timelines and KPIs for the oversight monitoring team globally
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
• Minimum 5 years of experience leading a team of CRAs
• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
• Experience working in Phase I – III clinical trials
• Recent experience working on trials utilizing risk-based monitoring models
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year, travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
• This position may also require US and international travel to clinical sites and/or medical conferences

The anticipated salary range for candidates for this role will be $180,000-$205,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

The Senior Manager of Clinical Systems serves as the clinical systems manager and technical lead for clinical technology initiatives. This position is responsible for the oversight, planning, and execution of end-to-end clinical system processes from start up through archival. This role combines clinical systems expertise with strong technical project management capabilities, ensuring successful delivery of system implementations, integrations, and enhancements.

This position will provide technical and business management in support of system compliance and inspection readiness, while driving structured execution of cross-functional initiatives. The role requires strong collaboration across Clinical, IT, Quality, and external vendors to manage timelines, risks, dependencies, and change management activities. This position will also lead efforts to define requirements, promote adoption of processes and standards, act as a point of escalation and ensure alignment with company goals, culture, and vision.

Key Responsibilities

• Provide clinical system guidance as a Subject Matter Expert (SME) for clinical system operations and requirements across study team functions, CROs, and vendors.
• Lead and manage clinical system programs and projects end-to-end, including scope definition, planning, timeline management, resource coordination, and execution tracking.
• Manage and support clinical system (insourced and outsourced) related projects, with a focus on IRT, site portals, CTMS and eCOA, acting as a project/program manager.
• Establish and maintain project governance, including risk management, issue tracking, dependency management, and executive status reporting.
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner.
• Translate business and clinical requirements into technical specifications, ensuring alignment with IT, validation, and vendor teams for successful system implementation.
• Ensure compliance with clinical system SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles, applicable regulations, GCP requirements, and industry standards.
• Generate and report KPIs, metrics and analytics, identifying trends across the clinical systems portfolio, areas for improvement, and implementing changes as needed.
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required.
• Lead and support development and implementation of processes, procedures, supporting tools, and related training materials that adhere to regulatory requirements and industry best practices.
• Collaborate with Information Technology (IT), Quality Assurance, and Clinical System Validation teams to ensure effective system implementation, integration, and lifecycle management, including releases, updates, bug fixes, and enhancements.
• Oversee system integrations and data flows across platforms (e.g., CTMS, IRT, eCOA, eTMF, LMS), ensuring data integrity and interoperability.
• Create and provide clinical system training. Act as a primary support role for clinical system users and stakeholders.
• Execute change management activities to ensure consistent application of revised standards, processes, and systems functionality, including validation.

Ideal Candidate (Enhanced with Technical PM requirements)

• Bachelor's Degree or higher or equivalent experience.
• At least 10 years of experience successfully managing clinical system activities for clinical research/biotech/pharmaceutical organizations.
• Experience implementing and managing eCOA, IRT, eTMF, CTMS and LMS (Veeva Vault experience preferred).
• Experience with implementation and integration of clinical systems and writing/revising SOPs related to clinical systems.
• Experience with computer system validation/assurance processes.
• Demonstrated experience applying project management methodologies (Agile, Waterfall, or hybrid) to deliver complex, cross-functional technical initiatives.
• Proven ability to define project scope, timelines, milestones, and resource plans, and manage execution with clear accountability.
• Strong program management skills, including risk management, dependency tracking, issue escalation, and stakeholder communication.
• Working knowledge of data management principles, including data quality, data governance, and data lifecycle management in clinical systems environments.
• Ability to interpret and analyze data outputs, dashboards, and KPIs to drive operational decisions and continuous improvement.
• Familiarity with AI/ML concepts and terminology (e.g., automation, predictive analytics, NLP) and their practical applications in clinical operations.
• Familiarity with software development lifecycle (SDLC) processes, including requirements gathering, UAT, release management, and post-implementation support.
• Proficiency with project management and tracking tools (e.g., Smartsheet, MS Project, or similar).
• Experience managing teams in the successful execution of projects; knowledge of records management practices in pharma/biotech or CRO environments.
• Strong software and computer skills, including Microsoft Office applications.
• Knowledge of relevant licensing and industry compliance regulations.
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Demonstrated effective written and verbal communication skills with internal and external stakeholders, including the ability to communicate complex technical concepts clearly.
• Able to lead initiatives and communicate effectively through presentations for external and internal audiences.
• Excellent organizational skills with outstanding attention to detail and follow-through.
• Able to work independently and function as a team player.
• Able to navigate complex problems, develop advanced concepts, anticipate challenges, and propose solutions.

Optional

• PMP, PgMP, or equivalent certification preferred.
• Experience in high-growth biotech or startup environments.

The anticipated salary range for candidates for this role will be $150,000-$165,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

We are seeking an Associate Director, Clinical Operations Standards and Planning to join our Clinical Operations Team. This position will be responsible for the identification, documentation, maintenance and optimization of Apogee Clinical Operations standards and best practices to support a growing portfolio of global clinical trials. This position will lead the Clinical Operations organization to identify innovative strategies to increase operational efficiency across programs.  Additionally, this role will provide oversight of the Clinical Operations resource planning process to support the Clinical Operations Leadership Team in ensuring appropriate resources are available at the right time to support the Apogee portfolio. This role will report into the Executive Director Process and Strategic Planning and will be a key leader within the Clinical Trial Excellence Team.

Key Responsibilities

• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team
• Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation
• Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s
• Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness
• Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization
• Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization
• Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally
• Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources
• Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements
• Lead and participate in key process improvement initiatives to ensure continuous process improvement
• Lead any assigned departmental activities to support a highly functioning Clin Ops organization

Ideal Candidate

• Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role
• Bachelor’s degree required
• Experience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendors
• Experience driving innovation in clinical trial operations to increase efficiency and implement best practices
• Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence
• Experience managing CROs, vendors and/or clinical trial consultants
• Strong leadership, communication, and interpersonal skills, with the ability to influence and align diverse groups across functions at all levels of the organization
• Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations
• Systems thinker with process optimization mindset and ability to build structure in dynamic, high-growth environments
• Strong project management skills, effective matrix leadership, and the ability to deliver
• Strong analytical and forecasting capabilities with demonstrated experience in capacity modeling, utilization optimization, and data-driven decision-making
• Ability and thrive in a fast paced, dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 30% travel

The anticipated salary range for candidates for this role will be $175,000 - $195,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. 

Key Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met 
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
• Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
• Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC)
• Participate in data cleaning and manage database lock activities with cross functional team
• Oversee review and approve essential document packages to enable timely site activations
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Participate in TMF review and ensure quality and completeness throughout end of the study
• Ensure the study is always “inspection ready” 
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project 

Ideal Candidate

• Bachelor’s degree in life science or equivalent
• Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization.  Biotech experience strongly preferred.  
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Proven proficiency in overseeing complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
• Experience selecting and managing clinical vendors to support study activities
• Enjoys building relationships with KOLs and site personnel
• Demonstrated ability to build and deliver on patient enrolment strategies
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to review and comprehend complex scientific concepts and clinical data
• Strong planning, time management, and coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Excellent written and oral communication skills
• Position requires up to 35%travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. 

The anticipated salary range for candidates for this role will be $145,000- $160,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Clinical Monitoring Manager to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The Clinical Monitoring Manager has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, sponsor monitoring or co-monitoring visits at the clinical study sites.

The Clinical Monitoring Manager collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.

Key Responsibilities

In-house responsibilities

• The Clinical Monitoring Manager is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• May be responsible for the hiring of in-house CRAs
• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plans, site visit report templates, monitoring tools)
• Support the training and development of in-house CRAs and ensuring study training compliance is maintained
• Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
• Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Responsible for oversight of CRA review of clinical data (e.g., electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with review and revision of departmental SOPs and policies
• Assist with creation and delivery of new department initiatives, improvement plans or training
• May assist with the identification and selection of appropriate clinical trial sites and investigators

Field monitoring responsibilities

• Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
• Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
• Minimum 2 years of experience leading a team of CRAs
• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials a plus
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Recent experience working on trials utilizing risk-based monitoring models
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.
• Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

The anticipated salary range for candidates for this role will be $150,000 - $170,000. per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.