Job for Pharmacy graduates as Senior Project Manager at CDSA | Emoluments upto Rs 1,10,000/- pm

 

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.

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

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

Candidate Profile
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:
• 5 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

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 includecommitment 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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