Study Manager, Clinical Operations

US-NJ-Princeton
Category
Clinical
Type
Regular Full-Time

Position Summary

In conjunction with internal management, the Study Manager (SM)

organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The SM is responsible for ensuring clinical study quality/consistency of performance and in conjunction within Clinical Operations and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. A critical component of the position is the peer management and/or support of and coordination with contract research organization personnel (CROs), consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies for which the SM is responsible.

 

Some travel is required.

Responsibilities

 

  • Assumes overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial contracts with internal team, CROs & study sites.
  • In conjunction with internal management, works with CROs to develop electronic systems, establish processes and plans, mitigation strategies, etc. in order to establish a foundation for clinical trials.
  • Identifies study specific training with the CROs Project Manager for implementation with GRAs and other clinical staff with topics that include team communication, computer software and IT training, protocol and CRF, adverse event reporting and the importance of pharmacovigilance.
  • Has responsibility for the financial management of the clinical trial study in conjunction with supervisor and finance department.
  • Establishes procedures to ensure adherence to trial protocols and administrative requirements.
  • Efficiently maintains and manages the tracking of timeline milestones for all studies as well as overall day-to-day operations of clinical studies.
  • Ensures the timely recruitment of trial participants with secure randomization processes (if applicable) and subsequent efficient and effective data management.
  • Monitors the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
  • Works to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
  • Participates on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
  • Develops systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
  • Ensures that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
  • Acts as the point of contact for all external and internal functional teams.
  • In conjunction with internal management, liaises with the Trials Steering Committee and Data Monitoring and Ethics Committee as required.
  • Provides regular       and ad hoc       information, both written       and verbal, to       all the trial participants, internal/external teams to include reports, updates, guidance, preformed commitments and, possibly, a newsletter.
  • If required and when applicable, co-monitors or performs CRA activities.       These responsibilities are inclusive of but not limited to the following:
  • Acts as the main line of communication between the sponsor and the investigator.
  • Locates and assesses the suitability of facilities at a study center. Verifies that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout.
  • Ensures the setting up of study centers, which includes ensuring each center has the trial materials and training the site staff to trial-specific industry standards.
  • Responsible for the safety and proper conduct throughout the trial.
  • Verifies that the investigator follows the approved protocol and all GCP procedures.
  • Verifying that source data/documents and other trial records are accurate, complete, and maintained through review of monitoring reports or co-monitoring visits.
  • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs. Verifies that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
  • Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
  • Works with internal and external functional teams to ensure all used and unused trial supplies are accounted for.
  • Manages the closing down of study centers on completion of the trial.
  • Provides support to a clinical team including maintenance of documentation, clinical tracking and information retrieval.
  • Prepares and manages clinical documentation and reports.
  • Serves as a central contact for communications/correspondence and associated documentation.
  • Manages and coordinates internal/external team meetings and internal/external investigator meetings.

Qualifications

Educational Requirements:  

·         AA or 4-year degree preferably in the biological sciences.  Requires a good understanding of medical terminology.

Experience:

·         3 years clinical trial management experience in the pharmaceutical industry preferably with 5+ in clinical operations.

Other Skills and Abilities:

·         Attention to details.

·         Solution oriented and exceptional collaboration skills.

·         A team player and able to work in a dynamic environment with attention to high quality reslts.

·         Understand the needs of others.

·         Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.

·         Well organized.

·         Excellent communication skills both verbal and written.

·         Professional in appearance and manner.

·         Ability to multi-task effectively and efficiently on a variety of projects.

·         Good team player with positive "can do" attitude.

·         Ability to focus on projects and work with minimal supervision.

·         Good proofreading skills.

·         Takes initiative and utilizes good judgment.

Language Skills:

·         Ability to effectively present information and respond to questions internally and externally.

·         Open and clear communicator.

Mathematical Skills:

·         Ability to work with mathematic concepts such as probabilities and statistics.

·         Ability to apply concepts such as proportions, fractions, percentages, to practical situations.

Reasoning Ability:

·         Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.

Computer Skills:

·         Outstanding computer skills in Word, Excel, PowerPoint, and MS Project

Physical Demands:

·         While performing the duties of this job, the employee is frequently required to sit, talk and hear

·         The employee is occasionally required to walk.

Work Environment:

  • The noise level in the work environment is usually quiet.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.   The requirements listed above are representative of the knowledge, skill, and/or ability required.   Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

 

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