Reports to:  Director, Clinical Operations

Summary/Objective

The primary responsibility of the Clinical Trial Manager II is to manage the day-to-day Clinical Operation activities associated with the execution of clinical studies. This position provides leadership and functional oversight to the various study teams, serves as the primary contact regarding all program activities and may act to advise study team members.

Essential Functions

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

 

  • Manage multiple external vendors and contract research organizations (CROs), as needed.
  • Prepare or contribute to the development of study documents such as the Monitoring Manuals, Study Operations Manuals, Source Data Verification Plan and Laboratory Manuals
  • Coordinate and be responsible for the design of study materials such as CRF’s, source documents, Informed Consent Forms, etc.
  • Assist with protocol development and study report completion
  • Manage monitoring activities (may include routine on-site co-monitoring at clinical study sites to ensure adherence to Good Clinical Practices (GCPs), SOPs and overall CRO oversight
  • Provide study tools to the CRA teams
  • Assist in tracking patient enrollment; track the site initiation visits, interim monitoring and close-out visits of sites, and review trip reports; and assist in coordination of data management activities
  • Coordinate study supplies as needed
  • May assist with generating request for proposals, reviewing bids, assisting with the negotiation of contracts with vendors of clinical trial services
  • Plan and participate in investigator meetings
  • Review of data listings, issue and query resolution; and assist and support data query process
  • Assure regulatory compliance of investigational sites with Quark Pharmaceuticals’ SOPs and FDA and ICH guidelines
  • Develops and reports key executional metrics for the oversight of the clinical trials
  • Ensure aspects of the trial master file are current and maintained in preparation for audits and inspections

 

Competencies

Functional/Technical Skills

Informing

Listening

Organizing

Problem Solving

Process Management

Peer and Vendor Relationships

Escalation management and problem resolution

Data base review

Good Clinical Practice

 

Supervisory Responsibility

 

This position has no direct supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

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 talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.

Travel

Some travel is expected for this position.

Required Education and Experience

Typically requires a Bachelor’s degree in a Life Sciences discipline and a minimum of 5 years of relevant clinical trials experience, with at least 4 years of experience as a Clinical Research Associate (CRA) or Clinical Trial Assistant (CTA) in the pharmaceutical industry. Without degree, additional related experience is required.

Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations

Demonstrated ability to work independently and in a team environment

Proficiency with MS Office (Word, Excel, PowerPoint, Outlook)

Excellent oral and written communication skills and strong organizational abilities

Additional Eligibility Qualifications

  1. Computer proficiency and technical aptitude with the ability to use Microsoft products.
  2. Experience in working within clinical data base systems, Medidata RAVE, a plus.
  3. Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.

AAP/EEO Statement

Equal Employment Opportunity Employer

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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