Job Detail

 

Summary 

This position is accountable, under the leadership of the Clinical Trial Head/or Sr. Clinical Trial Head, of all aspects of clinical trial(s). The responsibilities would include: (1) Provide input to the overall operational trial(s) implementation (2) Manage trial(s) timelines,  budget, feasibility, country identification and sites selection, enhanced patient recruitment (3) function as the primary liaison for internal stakeholders and vendors, as appropriate (4) Lead multidisciplinary departments initiatives (5) provide support for process changes to increase efficiency in study executions. 

 

Duties and Responsibilities  

• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality

 

• Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents;

 

• Manage the evaluation and selection of investigative sites; responsible for feasibility 

 

• Select, coordinate and monitor activities of vendors 

 

• Review of monitoring reports and conduct co-monitoring visits, as needed

 

• Develop and manage trial(s) timelines, budget and priorities; 

 

• Participate in data review and discrepancy resolution

 

• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress

 

• Generate reports to update management on conduct of trial 

 

• Ensure appropriate clinical trial supply plans are implemented and managed

 

• Develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required

 

• Participate in monitoring study safety

 

• Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team  

 

• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work 

 

• Assist with CRA and third party vendor training on protocols and practices 

 

• Lead the multi-disciplinary trials teams; include the study team meetings

 

• Function as the primary contact for trial(s) between Drug Development and other departments;

 

• Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department

 

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations. 

 

Requirements

  

• BS/BA degree or a relevant degree with strong emphasis on science;

 

• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials

 

• Able to manage complex and/or large trials

 

• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience 

 

• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

 

• Demonstrated leadership and problem solving skills

 

• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report) 

 

• Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment

 

• Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently

 

• Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships

   

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