Job for Consultant- Clinical Data Management in CDSA - M.Pharm/M.Sc

Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions. It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.

Post: Consultant- Clinical Data Management

Emoluments: (up to Rs. 75,000/- per month consolidated)

Qualification: Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred)

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.

Experience:

8-15 years in clinical data management with at least 5 years of management experience.
Sound understanding of the global drug development process.
Ability to develop/advise on training programs for Data Scientists/Technicians and data management workshops for Clinical Research staff.
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).
Experience 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

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Job profile:

Take responsibility for managing Data Management.
Provide technical leadership, resource management and project management for the required technical aspects supporting clinical trial 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.

GENERAL TERMS & CONDITIONS:

All educational professional and technical qualification should be from a recognized Board/ University and full-time.
The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
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_________” to cdsa_admin@thsti.res.in Applications will be accepted up to December 16, 2013. This will not apply for the walk-in-interview position.
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. Only shortlisted candidates will be contacted for further discussion.
All positions are contractual and will be guided by the provisions of contract career path cdsaindia.in/cdsa-contract-career-path developed by CDSA for its employees. Please review the contract career path before applying for any of the positions.
The Consultancy fee is a consolidated sum without any other benefits. Salaries mentioned against each position are indicative and actual salary will be based on experience, qualifications, skill set, etc. of the candidates.
Incomplete applications will stand summarily rejected without assigning any reasons.
Canvassing in any form will be a disqualification.

An extra mural unit of Translational Health Science & Technology Institute
Department of Biotechnology, Ministry of Science & Technology, Govt. of India
470 Udyog Vihar, Phase III, Gurgaon 122016

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