Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.

Post : Program Manager – CPM, CDSA

Emoluments : Up to Rs 1,00,000/- per month

Duration : (One Year)

Location : CDSA Office, Faridabad

Age Limit : Upto 45 Years

Qualifications and Experience
Education:
Essential
• 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.

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 upto 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 Memorandum’s 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 trouble shooting 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).

B. OPERATIONS MANAGEMENT:
• Oversee a portfolio of studies
• Organize meetings with clients (Investigators/ sponsor) to understand and negotiate the scope of the contract/ work and any Services Agreement in place for the client
• Prepare the Scope of Work for a assigned study/ trial
• Oversee preparation of initial budget for the project and support the finance department in preparation of budget for carrying out the assigned Scope of Work
• Review the Scope of Work with appropriate functional heads to identify staff necessary for the project team
• Prepare the project management plan, quality monitoring plan, safety monitoring plan, etc depending on the scope of work for the assigned study
• Support overall planning of the study with the investigator or team leading each project. Activities include but are not limited to early involvement in trial planning and budgeting, site level budgeting, site selection and evaluation, trial drug forecasting and negotiation with external providers, trial operational risk assessment, development of the data monitoring plan and trial team training.
• Input into study/trial protocols, informed consent forms, CRFs, and other trial related documentation
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Support the client/ investigator in preparing the dossier for submission to IEC/ regulatory agencies/ HMSC, etc
• Review and support the investigators to finalize responses to IEC/ regulatory agencies/ HMSC, etc
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings as required
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committee (DSMC) and other committees, clinical/ product development planning meetings
• Provide or support project-related training as needed for team members
• Initiate the project following Best Practices in Project Management
• Attend and represent project management/ contracted services at internal meetings and investigator meetings
• Ensure information entered into management system is accurate, and updated on a regular basis
• Ensure the project is progressing according to quality standards, SOPs, regulations, and guidelines
• Use project management plan as a tool to record and measure progress, updating as necessary
• Track resources and actual time spent on each project task for all team members to evaluate project progress
• Determine the cause of project overruns, discuss with line manager, recommend and institute corrective action, with input from functional Primaries
• Follow through on actions required
• Ensure the project is completed within the budget, schedule, and according to contract specifications
• Line manage project management staff within portfolio and manage with the Director CPM any performance management issues which arise with assigned staff
• Support the study/trial teams in their development, mentoring new trial and quality managers.
• Supporting the Director, CPM in preparing or contributing to the production of any type of clinical document, for either internal CDSA customers or external clients, for investigational drugs, biologicals, or medical devices
• Revise SOPs or suggest process improvements for consideration.
• Support the Director, CPM in business development activities.

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C. QUALITY MONITORING:
• Work with investigators/ sponsor prior to start of project on incorporation of quality management processes into the scientific and operational design of the trial
• To offer support to investigators/ sponsor to ensure compliance with applicable regulations and policies;
• Oversight of safety data processes within the portfolio
• Develop a monitoring plan with project investigators that is tailored to the specific human subject protection and data integrity risks of the trial
• Agree predefined quality tolerance limits to identify systematic issues that can impact subject safety or reliability of trial results
• Provide advice and support for site feasibility
• Oversight for quality monitoring as per the approved plans.
• Visit sites and participating institutes as and when required

D. COMMUNICATIONS:
• Serve as primary contact from CDSA for the project
• Communicate to team members the scope of work, timeline and project goals, technical information, and input from client throughout the project
• Inform team members of any new information or modification of project-related issues which may affect specific responsibilities of team members
• Work with appropriate Managers (project/ quality) on any anticipated need for addition or re-assignment of resources
• Communicating with study investigators for evaluation of status of patient recruitment and progress to study timelines; supporting safety reporting and IEC submissions; maintaining and reporting metrics for clinical site performance
• Provide Line Manager with input regarding team members’ performance as needed for employees’ periodic Performance Review
• Prepare administrative/ monitoring/ safety reports and submit to clients as required by the contract exhibit
• Communicate fiscal, contractual, resource, deliverable and client-related issues to Director CPM as appropriate

E. TRAINING:
• Develop project specific and protocol specific training
• Provide guidance and operational area training for project team members and staff as required
• Act as mentor for study staff and oversight for their training and development.
• To develop detailed understanding and provide guidance to the study team on the implications for clinical research of specific regulations and guidance such as the clinical trials regulations, Data Protection Act, and the regulatory and logistic aspects of international trials
• Faculty for training programs conducted by CDSA

F. RESEARCH:
• To coordinate a monthly journal club
• To contribute to reviews/commentaries
• To contribute to original research in design and conduct of trials/studies including contribution to study design, funding applications, conduct, data analysis and drafting of publications

Skills
• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegation, drive and timely/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment
• Business/ Operational skills that include commitment to quality management and problem solving
• Influencing skills including mhnbvegotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Computer literacy in Word, Excel, PowerPoint, Access or other trial management systems
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively in the manuscripts
• Ability to develop and implement monitoring plans and SOPs
• Ability to make evaluative judgments, remain flexible as projects and priorities change
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects

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GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and and the number of the position and the other requirements for the posts are relaxable at the discretion of the competent authority, in case of candidates who are otherwise suitable. Candidates not found suitable for the posts notified, can be offered a lower post on the recommendation of the Selection Committee.
5. No TA/DA will be admissible to appear in the interview, including (SC/ST candidates).
6. Only candidates who can join immediately needs to apply, as the position is to be filled on an urgent basis.
7. This position will be purely on temporary positon for a duration of One Year.
8. In case a large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher/relevant qualification.
9. Only shortlisted candidates will be called for Written test/Interview. Request for change in Written test/ Interview schedule will not be entertained under any circumstances.
10. The salary is a consolidated sum without any other benefits and it is based on experience, qualifications, skill set, etc. of the candidates.
11. Incomplete applications without assigning any reasons and the application form to be filled in without which the application will be summarily rejected.
12. All results will be published on our website and all future communications will be only through email.
13. This position is based at CDSA Office, Faridabad located at NCR Biotech Science Cluster at Faridabad Gurgaon-Expressway, Faridabad.
14. Canvassing in any form will be a disqualification.
15. Submission of application will be thru online mode only otherwise it will get rejected or ignored.

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:
• Matriculation Mark sheet
• Intermediate Mark sheet
• Graduation Degree/Mark Sheet
• Post-Graduation Degree/Mark Sheet
• Ph.D degree
• Relevant experience certificates
• Caste certificate in the format prescribed by the Govt. of India, if applicable
• Disability certificate in the format prescribed by the Govt. of India, if applicable
• List of Publications (if any)
• 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. Those who have applied once need not to apply again.
f. Only technical queries will be resolved (if any), other than technical will not be entertained.
g. On successful submission of your application, an auto-generated email containing a reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.