If you have relevant experience and would like to be part of ClinTech Research family, please send your resume to career@clintechresearch.com for further consideration.

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Business Development Director/Manager
Responsibilities:

• Looking for a goal oriented sales professional who will proactively manage all business development activities for targeted business area in accordance with the strategic goals of the company.
• To develop and lead implementation of strategies which shape future business delivery and provide the best possible service and information to stakeholders.
• Responsibilities include representing the company at client meetings, local and national exhibits, trade shows and conferences.
• Candidate will identify and develop business and cultivate existing client relationships by developing outstanding rapport with clients and business partners.
• Must be self-motivated and have the ability to meet or exceed company goals while working independently.
• Will rely on extensive experience and personal judgment to plan and accomplish sales goals.
• Perform other duties as assigned by the management.

Qualification/Requirements:

• 2-5 years CRO and pharmaceutical related experience in business development with a proven track record of achieving results with mid and high level decision makers.
• Bachelor's degree in sales, marketing, business or physical sciences (or related area of study); or equivalent combination of education and experience.
• Must have knowledge of the full-service CRO (Clinical Research Organization) industry.
• Proficient in use of MS Office (Word, Excel and Access).
• Candidate must possess strong work ethic and excellent oral and written communication skills.
• Willingness to travel- regional, national and international.

Clinical Research Associate (CRA)

Responsibilities:

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits for Phase II to IV studies.
• Visits to include monitoring of proper informed consent procedures, compliance with protocol in accordance with GCP/ICH Guidelines and other applicable regulatory requirements.
• Detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Report to project team, client, and site personnel any findings noted at monitoring visits followed by completion of monitoring reports and follow-up letters within the project-specific timelines.
• Maintain project tracking system of subject and site information.
• Participate in company-required training programs.
• Perform other duties as assigned by the management.

Qualification/Requirements:

• Minimum 2 years post-degree experience in Clinical Research (GCP Trained).
• Graduates/PG in life sciences, B.Pharm, M.Pharm, M.B.B.S or PhD qualification or equivalent.
• Proficient in use of MS Office (Word, Excel and Access).
• Willingness to travel- regional, national and international.

QA/QC Manager

Responsibilities:

• The preparation of the companies QA manual consistent with the company's policy together with national and international standards.
• Preparation, control and the distribution of all the companies' quality documentation and amendments and revisions including procedures and manuals in accordance with regulations and customer's specifications.
• Monitor all quality related activities on the project and quality audits of the clinical data and investigator sites.
• Review quality inspection, personnel qualifications and training requirements.
• Coordinate all QA/QC activities

Qualification/Requirements:

• Minimum 5 years post-degree experience in Clinical Research with at least 02 years in Clinical Quality Assurance.
• Graduates/PG in life sciences, B.Pharm, M.Pharm M.B.B.S or PhD qualification or equivalent.
• Proficient in use of MS Office (Word, Excel and Access).
• Willingness to travel - regional, national and international.

BA/BE Monitor

Responsibilities:

• Perform routine monitoring for BA/BE Studies.
• Visits to include monitoring of proper informed consent procedures, compliance with protocol in accordance with GCP/ICH Guidelines and other applicable regulatory requirements.
• Detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Report to project team, client, and site personnel any findings noted at monitoring visits followed by completion of monitoring reports and follow-up letters within the project-specific timelines.
• Maintain project tracking system of subject and site information.
• Participate in company-required training programs.
• Perform other duties as assigned by the management.

Qualification/Requirements:

• Minimum 2 years post-degree experience in BA/BE studies (GCP Trained).
• Graduates/PG in life sciences, B.Pharm, M.Pharm M.B.B.S or PhD qualification or equivalent.
• Proficient in use of MS Office (Word, Excel and Access).
• Willingness to travel - regional, national and international.

GLP Auditor/Monitor

Responsibilities:

• Assure contract laboratories conducting or supporting nonclinical development are qualified from the GLP compliance perspective prior to use.
• Inspects each non-clinical laboratory study at intervals adequate to assure the integrity of the study and that any problems determined through inspections which could affect study integrity are brought to the immediate attention of the study director and management.
• Periodically submits to management and the study director written status reports on each study, noting any problems and corrective actions taken.
• Determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
• Reviews the final study report to assure the report accurately describes the methods and standard operating procedures, and that the reported results reflect the raw data of the nonclinical laboratory study.
• Partner, interact closely and establish strong liaison with global business partners in Research & Development.
• Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals.
• Assist in the review and development of Nonclinical Development SOPs and Working Practices.
• Assist in preparation of budget and strategic plan for GLP studies.
• Perform other duties as assigned by the management.

Qualification/Requirements:

• 2-5 Years of experience in conducting nonclinical laboratory studies and auditing nonclinical studies for compliance with Good Laboratory Practice (GLP) regulations in the pharmaceutical industry or contract laboratories.
• Thorough knowledge of the nonclinical drug development process.
• Thorough understanding of FDA GLP regulations, OECD GLP Principles and local GLP requirements.
• Excellent interpersonal, facilitation, presentation and communication skills with demonstrable tact and diplomacy.
• Experience developing, implementing and evaluating SOPs
.
• Proficient in use of MS Office (Word, Excel and Access).
• Willingness to travel - regional, national and international.