Senior Clinical Manager

New Delhi, India
[Closing date: June 25, 2017]

 

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.

Opened in 2004, the DNDi India office supports the implementation of R&D projects on visceral leishmaniasis, along with activities in hepatitis C and paediatric HIV. The office also works closely on raising awareness and advocating for increased public responsibility and a more enabling environment for neglected disease R&D. R&D is the core of DNDi, representing over half of staff, located both in the Geneva office and the regional offices.

 

Position objective

The Senior Clinical Manager has the lead role in Managing Clinical Research Projects in India.

 

Responsibilities

  • 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.

 

Reporting line

Directly reports to the Head – DNDi, India RO. Also, has functional reporting to heads of respective research team.

 

Interactions

Works with entire DNDi India team (Executive, Communications, R&D, Project, and Operations). Works with project consultants, service providers, collaborators, and partners within the project network. Works on the organization of representation of DNDi at smaller events and with external stakeholders of equivalent level.

 

Required Competencies

  • 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.

 

Qualification & Experience

  • MBBS / MD degree holder, registered with Medical Council of India or state medical council OR M Pharm / MSc degree holder.
  • Minimum 8 years’ relevant experience in clinical trials research with at least 3 years in the leadership role of managing the research team.
  • Knowledge and expertise in ethics / regulatory documentation (EC, DCGI and HMSC submission).
  • Experience in preparation and review of clinical research SOPs and other standard documents required for conducting clinical trials / studies.
  • Proven ability to work effectively in a team environment and matrix structure.
  • Experience in Public health would be an advantage.
  • Experience of working in international NGOs will be an added advantage.

This role offers excellent opportunities for personal and professional development. Travel to project locations and other regions will be required. Some international travel will be required.

 

To apply

  • Deadline for application: June 25th, 2017.
  • Only shortlisted candidates will be contacted.