This is a pharmaceutical company that specializes in developing innovative therapeutics to treat cancer.
Position Title: Study Manager, Clinical Operations — JO#2109-5636
The Study Manager manages the planning, coordination, tracking, and general performance of clinical studies that support the Clinical Development Plan.
S/he will ensure clinical study quality and consistency of performance, including enforcing overall timeline adherence and performance against the plan of the clinical study.
A critical component of the position is peer management and/or support of and coordination with Contract Research Organization personnel, consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies.
Reports to the Senior Director of Clinical Operations.
Essential Duties and Responsibilities
- Responsible for the operational tasks involved in study management and CRO oversight, including finalization of the monitoring plan; IRB/ethics committee approval; development of recruitment strategies to increase patient randomization into the trial; provision of clinical trial materials; management of the trial contracts with the internal team, CROs & study sites.
- Work with CROs to develop electronic systems, establish processes and plans, mitigation strategies, etc. in order to establish a foundation for clinical trials.
- Identify study-specific training with the CROs Project Manager for implementation with Clinical Research Associates and other clinical staff, including team communication, computer software and IT training, protocol and CRF, adverse event reporting, and the importance of pharmacovigilance.
- Responsible for the financial management of the clinical trial study in conjunction with the supervisor and finance department.
- Establish procedures to ensure adherence to trial protocols and administrative requirements. Maintain and manage the tracking of timeline milestones for all studies as well as overall day-to-day operations of clinical studies.
- Ensure the timely recruitment of trial participants with secure randomization processes (if applicable).
- Monitor the trial progress to ensure compliance with the project plan and to identify, evaluate, and rectify problems.
- Ensure that the trial is meeting its targets, is producing meaningful output, predict and plan for any changes that warrant requests to changes in protocol, funding, or time.
- Participate in corporate global clinical research teams.
- Develop systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
- Comply with all aspects of GCP at all times.
- Liaise with the Trials Steering Committee and Data Monitoring and Ethics Committee as required.
- Provide regular and ad-hoc information to all trial participants and internal and external teams.
- When required, co-monitor or perform CRA activities. These responsibilities are inclusive of but not limited to the following:
- Act as the primary line of communication between the sponsor and the investigator.
- Locate and assess the suitability of facilities at a study center.
- Verify that all research staff, facilities, and investigational products have adequate qualifications and resources and these remain adequate throughout.
- Ensure 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.
- Verify that the investigator follows the approved protocol and all GCP procedures.
- Verify that source data/documents and other trial records are accurate, complete, and maintained through a review of monitoring reports or co-monitoring visits.
- Ensure adverse events, concomitant medications, and intercurrent illnesses are reported in accordance with the protocol on the CRFs. Verifies that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
- Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
- Work with internal and external functional teams to ensure all used and unused trial supplies are tracked/accounted for.
- Manage the closing down of study centers on completion of the trial.
- Provide support to a clinical team, including maintenance of documentation, clinical tracking, and information retrieval. Prepare and manage clinical documentation and reports.
Qualifications (Education & Experience)
- A Bachelor or an Associate’s Degree preferably in Biological Sciences.
- At least 3 years of clinical trial management experience in the pharmaceutical industry, including at least one project managed through the entire study lifecycle.
- Experience with Phase I-III trials required, additional Phase IV experience preferred.
- Demonstrated depth of knowledge and understanding of Clinical Operations in a Trial setting.
- Experience working within US & European Trials, experience in other global markets would be nice to have.
- Excellent communication skills both verbal and written. Good proofreading skills. Proven ability to work independently once assigned a project, with minimal day-to-day oversight.
- Strong drive and motivation, including a willingness to research solutions to challenges.
- A firm knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
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