Clinical Development Services Agency (CDSA) mission is to create, develop, and nurture world-class clinical product development capacity in India.
Post: Full Time Consultant – Clinical Data Management
Emoluments/ Age limit: (up to Rs. 75,000/- per month consolidated) Age Limit: 45 years
Job Profile
- Take responsibility for managing Clinical Data Management.
- Provide technical leadership, resource management and project management for the required technical aspects supporting CDM activities.
- Ensure quality, timeline and productivity requirements are met or exceeded. Included in this are project planning and implementation, milestone tracking, organization and participation in team meetings, monitoring progress and providing updates as required
- Create, direct and maintain strategies in line with the Clinical Operations and/or Biostatistics organization to help facilitate efficiencies within the department.
- Manage a team local to a site to provide work direction task prioritization, supervision, assistance and career development to assigned tasks.
- Manage all phases of data management activities from study start up to database close and not limited to database set-up, CRF design, data entry, validation/ edit checks, data transfer, and any ad-hoc programming required to support a clinical trial process
- Lead cross-functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical studies.
- Identify and adequately resolve operational and technical problems. Manage process improvements.
- Communicate with the other operational groups regarding workflow, process, timelines, and resource planning to ensure transparency between the all functions as well as any external support groups.
- Define, develop and deploy appropriate operating procedures.
- Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/ Guidelines, GCP and any other applicable local regulations.
- Provide relevant training/mentoring for staff to assist them in resolution of problems encountered in the conduct of their daily work or on application of Clinical Systems.
- Co-ordinate the improvement and implementation of tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies and quality.
- Attend (as appropriate) client facing meetings to represent the CDM group on activities including, but not limited to, progress reviews, technical updates on key milestones, bid defences, technical requirements collection.
- Represent the CDM group at internal and external audits and regulatory inspections, as required.
Qualifications and Experience
- Bachelor’s degree level (life science or equivalent degree biological/pharmacy or other health related discipline preferred)
- 8+ years in core clinical data management function with at least 5 years of team management experience
- Sound understanding of the global drug development process
- Ability to develop/advise on training programs
- Ability to establish strong working relationships with others in the drug development process, particularly within Clinical Research
- Familiarity with SAS programming
- Well-versed in regulatory requirements for validation of data management systems, GxP, Good Clinical Data Management Practices (GCDMP)
- Additional Experience preferred in various phases of clinical trials with full project life cycle experience (CRF design to database lock and reporting); use of commercial and/ or proprietary clinical data management systems, coding dictionaries/ encoding systems (e.g. MedDRA, WHODRL), other software in support of data management activities (e.g SAS, Access, SQL, Oracle), programming skills and experience with electronic data capture a definite plus
Skills
- Good oral and written communication skills in English.
- Demonstrated ability to work independently and in a multidisciplinary team.
- Demonstrated ability to manage and motivate direct reports
- Excellent interpersonal, verbal and written communication skills, (including experience in making presentations at conferences, meetings, training sessions)
- Able to role model behaviours and ethics in line with CDSA Mission, Vision and Values
- IT literate
- Knowledge of SOPs/ Guidelines/ System Life Cycle methodologies, GCP and any other
- Applicable local regulations and proven practical application.
- Tenacity to work in an innovative environment.
- Personal skills include ability to manage competing priorities, function independently, attention to detail, excellent organizational skills, and flexibility to change and fulfilling activities to completion.
- Demonstrated ability to learn new systems and function in an evolving technical environment.
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 other requirements for the post can be relaxed at the discretion of the Chairman of the Interview Committee, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Consultant, Clinical Data Management (CDM)” to cdsa_admin@thsti.res.in
6. Only shortlisted candidates will be contacted for interview
7. Incomplete applications will stand summarily rejected without assigning any reasons
8. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc.. A 10% annual increase in salary is based on the performance
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
12. Canvassing in any form will be a disqualification.
13. The last day of application is every Saturday of the week. If candidates are short-listed, they will be called for interview on the following Friday or other days based on the availability of interviewees.
Those who have applied earlier need not apply again.
Recruitment Notice No. CDS/RN/03/2015
CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
An autonomous organization of Department of Biotechnology
Ministry of Science & Technology, Govt. of India
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)
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