Clinical Trial Manager/Sr. Clinical Trial Manager, Clinical Operations

Clinical Trial Manager/Sr. Clinical Trial Manager, Clinical Operations

Status:                        Exempt

Type:                          Full-Time

Reports to:                Executive Director or Senior Director, Clinical Operations

Summary

The Clinical Trial Manager/Sr. Clinical Trial Manager will play a key contributor role in the implementation and execution of clinical trial(s) from study start up to close-out. The incumbent will have responsibilities for the management and oversight of CRO's, study vendors and clinical trial sites, and will partner key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOP's. This is an on-site position.

Essential Functions

·        Develops and maintains good working relationships with CRO, investigators and study staff.

·        Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.

·        Ensures timely response to queries and monitoring discrepancies.

·        Assists with third-party vendor training on protocols and practices.

·        Tracks and reports on current progress of the study including site activation, patient enrollment, monitoring visits and data entry backlogs.

·        Supports the investigational product (IP) study drug accountability and reconciliation process.

·        Oversees the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.

·        Performs clinical data review of data listings and summary tables, including query generation.

·        Performs initial review of CRO and other third-party study vendor invoices for correctness.

·        Reviews and/or approve IP release packages.

·        Contributes to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.

·        Participates in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.

·        Ensures audit-ready condition of clinical trial documentation including clinical trial master files; reviews monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assist in the planning of regulatory or ethics committee activities, as appropriate.

·        Collaborates with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).

·        Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).

·        Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).

·        Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.

·        Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.

·        Perform other duties as assigned by supervisor.

Skills and Competencies

·        Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.

·        Therapeutic experience in oncology is strongly preferred.

·        Minimum 3 – 5 years’ experience managing clinical trials, preferably as the sponsor.

·        Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.

·        Experience monitoring sites and conducting other site management activities.

·        Ability to work in a fast-paced environment and flexibility

·        Proven experience in early phase clinical trials.

·        Strong site management and CRO management skills required.

·        Proven communicator, both oral and written.

Work Environment

This job operates in an office environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk, and hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position Type/Expected Hours of Work

This position is full-time, on-site at company offices; Monday through Friday.

Travel

Occasional travel may occur (up to 15%).

AAP/EEO Statement

The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Candidates only; please do not contact if you are a recruiter.