Clinical Study Manager

Summary:

Provides guidance and oversight to internal and external project team members for the successful management of all aspects study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols.

Primary Responsibilities:

• Prepares key reports on study progress and assists in delegated clinical study management responsibilities.

• Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables.

• Serves as contact for interacting with and conveying study information to data management, safety, regulatory personnel, and other functional or departmental groups, as necessary.

• Contributes to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry.

• Provides clinical input in the development of case report forms, data management plan, and data listings review.

• Participates in vendor selection and contributes to the RFP process.

• Provides input for site, study and/or vendor specific budgets, as needed.

• Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables, as necessary.

• Reviews site invoices to ensure that clinical expenses are in accordance with work conducted.

• Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate.

• Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs.

• Resolves escalated study conduct issues and provides clinical responses to questions from study centers and institutional review boards/ethics committees.

• Reviews escalated issues from CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and/or site audit report findings).

• Drafts, reviews and approves relevant documents, including informed consent, site worksheets, vendor site manuals (pharmacy, lab), monitoring reports.

• Ensures responses to site audits are adequately managed by designated clinical staff.

• Oversees integrity of clinical data to ensure data meets GCP standards, including identification of trends reported from vendors and via review of study data.

• Provides oversight of CTMS tracking to support evaluation and continual management of clinical study set-up and follow-up study activities, as needed.

• Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.

• Assists in the planning and coordination of investigator meetings, as necessary.

• Provides assistance in the management of the trial master file process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan.

Knowledge, Skills, and Abilities:

Advanced verbal, written and interpersonal skills that enable cross-functional issue resolution. Advanced strategic thinking abilities for proactive planning and decisive decision making. Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs. Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Advanced ability to train and mentor CRAs.

Requirements:

Bachelor’s degree. Typically requires 8 years of experience in clinical research, including 2 years in a study management/leadership role. Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.

Occupational Demands Form # 9: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States and internationally. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO/Minorities/Females/Disability/Veterans

Location: [[mfield6]]:[[cust_building]]

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