Job Ref: 214942111

Date: 2021-10-19 09:48:14

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The Clinical Trial Manager is responsible for overseeing and conducting clinical research trials. They will ensure that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials meets the requirements for Regulatory Authority approval.

Essential Functions Include:

* Oversee and manage CRA team and/or Clinical Trial Assistants, if applicable.

* May be responsible for multiple studies or programs.

* Function as primary resource for the client and cross-functional study team.

* Accountable for leading, and managing the process for the selection, contracting and oversight of CROs and/or clinical trial related third party vendors in collaboration with the study team and key stakeholders.

* Coordinate and manage clinical trials from start-up to closeout with contractual timelines, budget and expectations.

* Immediately escalate any out of scope services requested by Sponsor or necessary for continued study execution.

* Provide study-specific training for the assigned clinical operations staff.

* Evaluate and identify resourcing needs and continuously monitor over life cycle of the study.

* Manage processes to ensure completion of on-time, high quality deliverables within budget.

* Develop, analyze and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.

* Develop and maintain Study Project Plans including, but not limited to, site selection and monitoring plans, TMF management plan, payment plans, etc. Also responsible for creating, training on and updating study specific tools and templates to be used throughout the course of the trial.

* Provide strategic input into study documents such as study synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Safety Plan, Clinical Database edit specifications, Annotated Monitoring Visit Report templates, Clinical Study Report development, etc.

* Manages study drug product and non-drug site supplies (study materials/equipment/manuals), deliverable development, shipment, tracking accountability and resupply to sites.

* Manages the IRB submission process for start-up (protocol and other study documents); annual IRB update, protocol amendments and study close out.

* Develops the agenda and manages the planning and execution of Investigator Meetings: meeting vendor contracting and management, coordinate development of meeting agenda, content development and delivery of operational (non-Clinical Science) presentations and training materials, manage meeting execution and documentation; ensure input from key stakeholders.

* Responsible for the development and presentation of slides and training materials for various audiences

* Assists with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting.

* Ensures clinical study team compliance with applicable FDA regulations, ICH-GCPs, other local regulatory requirements and corporate SOPs.

* Develop subject recruitment/retention strategy and related initiatives.

* Collaborate and communicate with other functional areas to identify and evaluate fundamental issues on study related projects.

* Leads and/or participates in investigator, client and cross-functional team meetings.

* Oversee maintenance and quality review of study TMF.

* Develop and maintain tools for management of study deliverables (i.e., timelines, study plans, adherence to monitoring plan and TMF plan, etc.).

* Timeline, budget and resource management experience required

* Identify potential risks and develop escalation/action plans to avoid or mitigate issues and make the appropriate decisions balancing risks with study quality, deliverables and costs.

* Complete routine administrative tasks in a timely manner (e.g., metrics, submission/approval of timesheets and expense reports).

* Establish efficient / effective working relationships with other functional leaders and coordinators across geographies.

* Develops and implements risk management strategies and contingency plans for clinical deliverables.

* Ensures consistency and accuracy in site payment process if applicable.

* Approximately 20% travel may be required

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