Clinical Project Manager job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
To manage global clinical trials in different therapeutic areas (e.g., Respiratory, Dermatology, Oncology, others to be identified) 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 :
- Matrix-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
- 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
- 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.
- Doctorate, Masters or Bachelor's 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.
- Minimum of 6 years of Clinical Trial Management experience, of which 3 years should be in managerial role.
- It is recommended that the candidate 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 oncology clinical trials.
- Excellent written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders.
- Pleasing personality, assertive profile with good inter-personal skills and 'hands-on' approach.
- Self-starter/high on team working/influencing skills/maturity.
- Proactive, organized and flexible.
- Learns quickly in a rapidly evolving environment.
- Regional Sales Manager - Portfolio, Sun Ophthalmics (Memphis District) Sun Pharma Memphis
- Regional Sales Manager - Account Team, Sun Ophthalmics (Southeast) Sun Pharma NC, SC, GA)
- Territory Manager, Dermatology Photodynamic Therapy- Phoenix South Sun Pharma Phoenix