Job Description Template

Job Title: Clinical Trials Manager

Reports To (Position): Director Clinical Operations

Location: Redwood City, CA

Department Name: Clinical

HR Designations: Job Code

Band

Pay Status Exempt

Objective of Position Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. Provides training to clinical operations staff and performs performance appraisals of direct reports.

Key Accountabilities/Core Job Responsibilities § Responsible for the preparation and finalization of project and study-related documents

including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required

§ Responsible for the selection of investigators and study sites § Responsible for identifying and responding to site and study related issues and

recommending corrective actions and/or escalating to supervisor § Coordinates the design, format and content of CRFs, study guides, study reference

binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT

§ Ensures that CRF data queries are resolved § Coordinates and manages Investigational Product including overall accountability and

reconciliation § Responsible for the preparation of study budgets and timelines § Manages project timelines and vendor performance to meet departmental and corporate

goals § Manages study budget and payment process for all clinical trial vendors including

investigative sites § Monitors and tracks clinical trial progress and provide status update reports § Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG) § Responsible for selection of CRO study staff and coordinating training including

documentation § Hires, trains and oversees study Field Monitors (e.g., review of all trip reports) and

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provide guidance on site issues § Leads with minimal supervision in the planning of investigator meetings and making

presentations, as required § Leads the review of clinical data at the CRF, data listing, and report table levels § Represents Clinical Operations at the Project Team level for individual studies, as

appropriate § Partners with other research and development groups to achieve deliverables § Participates in Site Initiation Visits (SIVs) as required § Co-Monitors of regional sites for adherence to protocol and GCP as required § Identifies and escalates site, vendor and study related issues to supervisor, as

appropriate § Participates in clinical and department settings, including attending additional meetings

as required, and interacts in a positive and professional manner § Supervises Clinical Trial Assistants and Clinical Research Associates, and performs

performance appraisals § Performs other duties as assigned Requirements § Must have demonstrated expertise in relevant clinical operations activities § Ability to exercise independent judgment within generally defined practices and policies

that lead to methods or processes for obtaining results § Good organization and planning skills § Strong interpersonal skills and communication skills (both written and oral) § Ability to problem solve and delegate appropriate tasks to subordinates § Knowledge of ICH/GCP guidelines and FDA regulations § Strong leadership skills, self-motivated, adaptable to a dynamic environment § Able to collaborate effectively with the study team, cross-functional team members,

and external partners § Knowledge of ICH/GCP and FDA regulations § Proficiency in MS Word, Excel and PowerPoint Education/ Training § BA/BS/MS in a scientific discipline § 7+ years of relevant clinical experience in a CRO or pharmaceutical § At least 3 years of CRA experience and 2 years of study management experience § Experience in oncology preferred § Experience in global trials preferred Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor. APPROVALS

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