Clinical Project Manager
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Position Summary:
To manage global clinical trials in respiratory indications such as COPD, Asthma, and Allergic Rhinitis. with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams.
Key Responsibilities:
– Line/personnel management:
– Manage and direct the efforts of CRAs assigned to project. Manage performance, scheduling and work assignments.
– Define and communicate job descriptions, core competencies, performance standards and expectations.
– Coordinate regular meetings (at least the frequency of two meetings a month)
– Establish accurate and consistent productivity expectations and revise as needed.
– Financial management:
– Monitor expenditure of funds relative to budgetary targets for assigned trials on an ongoing basis. Ensure that variances are identified and communicated to the appropriate personnel in a timely manner.
– Facilitate efforts to implement appropriate interventions.
– Project management:
– To independently manage/handle assigned clinical study in-house or via CRO.
– Prepare the study budget in consultation with project management/line manager/business development for the assigned projects.
– Prepare the project/monitoring plan for the study/ies. Track and ensure that project timelines and milestones are being met. Maintain and update all trackers to evaluate the progress of the study.
– Identify and communicate delays the line manager/department head in a timely manner.
– Suggest and facilitate contingency planning and implementation in order to meet timelines.
– Implement the initiation of the study sites, with the appropriate follow up (co-monitoring, reviewing of reports, recruitment tracking) and close out (archiving of files, collecting of IP and trial materials) of study centers on the assigned projects.
– Lead and supervise the CRAs in activities for the clinical studies, delegate tasks commensurate with skill levels while increasing knowledge base.
– Assist in preparation of dossier and/or appropriate documentation for regulatory/ethics committee submission or other appropriate bodies on time as per required format.
– Provide creative solutions for issues impacting study and team members.
– Act as a key operational interface in the management of clinical studies.
– Provide clinical research expertise in support of other departments and line functions.
– Contribute in preparation and implementation of project specific training programs and training materials for internal and external staff.
– Perform other related duties incidental to the work for training and development.
– Develop and implement orientation programs for new team members including the ongoing training, continuing education and professional development programs for others.
– To perform the ongoing assessment for the direct reports and to recommend/facilitate in the conducting the necessary training for the team in the identified gap areas.
Requirements:
Education :
– Doctorate, Masters or Bachelors degree. Major course of study must be science or health related, eg. MPharm, BPharm, MBBS, M.Tech (BioTech) MSc, Nursing qualification, etc.
– Thorough understanding of clinical research process and ICH GCP.
Experience :
– Minimum of 6 years of Clinical trial management experience, of which 3 years should be in managerial role.
– The candidate should have worked for 2 years in the capacity of site monitor in phase I to III clinical trials either in CRO or a bio-pharmaceutical company.
– The candidate should have extensive experience running trials in respiratory indications such as COPD, Asthma, and Allergic Rhinitis.
Skills :
– Excellent written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders.
– Learns quickly in a rapidly evolving environment.
– Proactive, organized and flexible.
– Self-starter/high on team working/influencing skills/maturity.
– Pleasing personality, assertive profile with good inter-personal skills and 'hands-on' approach.
– Contributes to continuous improvement process.
– Involved in operational planning, analysis, risk management and resolution strategies.
EOE/M/F/Vet/Disabled
