CDSA Recruitment 2019 – Clinical Development Services Agency (An extra mural unit of THSTI, An autonomous organization of Department of Biotechnology Ministry of Science & Technology, Govt. of India) invites application for the position Program Manager in CDSA Read details, eligibility criteria mentioned below for the vacancy and eligible candidates can submit their application directly to Clinical Development Services Agency before 29-07-2019.
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Post: Program Manager - CDSA
No of Post: 01
Qualifications and Experience
Essential Qualification: Bachelor’s in medical sciences or Master’s degree/ diploma in life sciences, pharmacy, public health, healthcare or other related discipline
MBBS/ BDS/ BHMS/ BAMS/ BPT preferred or
Post graduate degree in a health related discipline
Advantageous
Postgraduate degree in Public Health
MD/DNB from a recognized Indian University/ recognized by MCI
PhD in a health related discipline
Work Experience:
Essential: 8 or more years of experience in clinical project management and/or clinical trial/ study monitoring.
Experience of clinical trial or public health project management in a recognized organization / institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company).
Advantageous:
- Demonstrable experience of leading a team
- Experience of line management
- Demonstrable application of project management concepts
- Demonstrated ability to understand, explain and communicate project concepts (project life cycle, scope planning, scheduling, implementation of project plan), and manage project conduct (schedule, quality, and cost control, risk and change management) using standard tools and templates
- Excellent interpersonal skills
- Experience of managing a complex public health study/ clinical trial of an IMP
- Highly developed communication skills both written and verbal
- Significant experience of project management in industry, major academic clinical trials unit or epidemiological/public health research setting
- Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
- Ability to evaluate risks inherent in clinical studies/ trials and decide those which should be prioritized to ensure that risks are properly managed
- Outstanding organizational skills, managing several projects that are often time pressured, concurrently. Ability to prioritize activities in spite of conflicting pressures
Emoluments: Up to Rs 1,00,000/- per month
Duration: One Year
Location: CDSA Office, Faridabad
Age Limit: Upto 45 Years
Job profile:
- To oversee the management of a portfolio of trials/ studies including project management, quality monitoring and/or safety monitoring and guiding the study teams to achieve successful completion of all assigned activities in the project
- To support the Director CPM and other team leads in the implementation of systems for resource planning, study/trial administration and document management, data management and quality assurance.
- To contribute to research in design and conduct of trials/studies.
- Provides Leadership to: Project Manager/ Clinical Trial Manager, Senior Research Officer/ Research Officer, Clinical Research Associate/ Study Monitor, and Project/Clinical Trial Assistant.
- Has direct line management responsibility for up to 5 Project / Clinical Trial Managers
- Works Closely with: Project Team Members, Site Study team (Project Coordinator, Investigators), Expert groups/ Committee, Regulatory Affairs, Medical Affairs & Medical Writing, Data Management, Biostatistics, Central Laboratory, key Institute staff on finance, administration, contracts and personnel matters.
- External relationships: Investigators, Clinical collaborators, Sponsor counterparts and management, third party contractors and regulatory authorities.
A. RESPONSIBILITIES AS LEADERSHIP AND STRATEGY:
- Support Director CPM on the development of systems for overseeing and reporting on clinical trials / studies and medical device portfolio
- Help develop mechanisms for prioritizing clinical trials/ studies for sponsorship
- Ensure consistent application of core CDSA policies and operating procedures across the CDSA sponsored trials/ studies portfolio
- Act as the lead on behalf of CDSA for projects, meeting with internal and external partners (academic and industry collaborations, vendors, sponsors and manufacturers and regulators)
- Continually review and respond to changes required to shape the infrastructure, functionality and standards of clinical trials/ studies management, including the development and implementation of systems, operating procedures and policies.
- Provide expert support to projects with regards to compliance, policy, sponsorship and high-risk studies
- Represent CDSA at regulatory inspections and meetings as required
- Support the Director CPM, collate project reports and write position papers as well as advising on “higher risk” studies and in the development of overall strategy
- Oversee and draft Memorandums of Understanding (MoU’s) or other documents to outline the delegation of duties from the sponsor office to CDSA and other stakeholders of the projects. This will be done with the Administrative Manager
- Actively contribute to or lead on initiatives related to the development of CDSA including resourcing, skills and training, systems and aligned risk assessments and strategies
- Support Director CPM for escalations and troubleshooting where issues or concerns are raised by researchers with regards to trials and “higher” risk studies
- Ensure the dissemination of information for CDSA staff on the CDSCO/ ICMR Clinical Trials Regulation and its implications, regulatory requirements, research governance and Good Clinical Practice (GCP).
Procedure for Filling Online Application:
a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (only jpeg/jpg format, file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 MB maximum) containing details of qualification, positions held, professional experience/distinctions etc.
iii) The documents in support of educational qualification and experience (PDF format only, file size 1 MB maximum) as mentioned below:
ü Matriculation Mark sheet
ü Intermediate Mark sheet
ü Graduation Degree/Mark Sheet
ü Post-Graduation Degree/Mark Sheet
ü Ph.D degree
ü Relevant experience certificates
ü Caste certificate in the format prescribed by the Govt. of India, if applicable
ü Disability certificate in the format prescribed by the Govt. of India, if applicable
ü List of Publications (if any)
ü List of patents (if any)
b. Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
c. Once online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in
e. On successful submission of your application, a pop up window will appear showing the reference number. Please keep a note of the reference number for future correspondence.
Last Date: 29/07/2019
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