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Apogee Therapeutics · 4 weeks ago

Clinical Monitoring Manager

United States

Full-time

Hybrid

Senior Level, Lead/Staff

$150K/yr - $170K/yr

8+ years exp

Apogee Therapeutics, Inc. is a biotechnology company focused on developing differentiated biologics for various inflammatory and immunology conditions. The Clinical Monitoring Manager will oversee in-house Oversight CRAs and manage clinical study site activities for Apogee sponsored clinical trials, ensuring compliance with regulations and quality standards.

BiotechnologyLife ScienceMedicalTherapeutics

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

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

Qualification

Clinical Research Associate certificationClinical trial managementClinical Practice (GCP)International Council for Harmonization (ICH) guidelinesMicrosoft Office SuiteElectronic data capture (EDC) systemsClinical trial databasesOrganizational skillsTime management skillsCommunication skillsInterpersonal skillsTeam collaborationAdaptability

Required

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

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

Preferred

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

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

Commitment to growing you professionally and providing access to resources to further your development

Apogee offers regular all team, in-person meetings to build relationships and problem solve