Job for Senior Clinical Manager at DNDI
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases.
Post : Senior Clinical Manager
- To liaise with the project consultants, service providers, collaborators and partners within the project network, including the State Health Society Bihar, State Programme Officer (KA) Bihar, NVBDCP, RMRIMS and MSF etc. for project discussions.
- Developing of clinical research project plans, protocol synopsis, protocols and schedules with the DNDi Project team, managing project related activities, coordinating with the investigators and monitoring milestones for project evaluation.
- Development of SOPs, conducting site visits, preparation and / or review of site visit reports, identifying and resolving issues that arise during study contact, training for study site teams.
- Preparing ethics / regulatory documentation (EC, DCGI and HMSC submission) and prepare / review clinical SOPs and other standard documents required for conducting clinical trials/ studies.
- Direct Supervision of CRO activities for the study and regular telecon with CRO team.
- Coordinate with different vendors involved in the study for various study related activities.
- Supervise reporting for Serious / Unexpected Adverse Events (SAE) reporting from the field.
- Travelling within Bihar frequently and required to travel to Bangladesh for project related activities
* Fluency in English and Hindi
* Proficiency in any other local languages desirable
* Good knowledge of Microsoft Office
* Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
* Clear and systematic thinking that demonstrates good judgment and problem solving competencies
* Strong communication skills in multicultural, multi-lingual environments
* Strong ability to work effectively as part of a multicultural team
* Well organized and structured
* Strong analytical skills
* Strong ability to provide high level support in project / program delivery
* Strong ability to manage medium/large projects with budget management
* Strategic thinking and leadership abilities as defined in the Leadership competency model
* Strong management, negotiation, and advocacy skills
* Has autonomy for taking actions and decisions
* Strong ability to interact with external stakeholders
* Lead and motivate a small team for optimum performance, supervising junior staff
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