Opening for the post of Clinical Trial Assistant at SIRO Clinpharm, India

Company Name: SIRO Clinpharm

Company Website: http://www.siroclinpharm.com

Post Name: Clinical Trial Assistant

Qualification: The incumbent should be a B. Sc graduate/ B. Com graduate

The core responsibilities for the position would be to provide in-house support to Clinical Operations team:

• Provide project support to project team members for all the trial related activities.
• Co-ordinate between the project team for different study related activities, issues, requests, meetings.
• Assist project lead in study related activities.
• Preparation and shipment of study related materials.
• Co-ordinate with third parties, e.g. couriers, translating agencies.
• Receipt, check for completeness and accuracy of administrative documents.
• Prepare, maintain and update the in-house trial related files according to SOPs, Indian/ Applicable Regulations and ICH GCP.
• Review in–house study files, proactively identify missing documents and bring it to the notice of all concerned.
• Coordination in Ethics committee submissions and preparation of site specific dossiers.
• Assist the Project Managers in preparation and submission of regulatory documents.
• Track study related documents, files, courier receipts etc.
• Maintain & update study specific trackers, weekly and monthly project status with the help of Project Manager.
• Coordinate & track of non-drug clinical trials supply management (clinical trial supplies other than Investigational Product) i.e. CRFs, other materials like diary cards, ICFs, DCFs, infusion pumps etc.
• Document Control i.e. Letters and also control of all Protocol, IB etc
• Maintain of site payment tracker and coordinate with Finance for release of payment on time.

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Mail your resume to: hr_india@siroclinpharm.com

Opening for the post of Executive/ Sr. Executive – CTSM at SIRO Clinpharm, India

Company Name: SIRO Clinpharm

Company Website: http://www.siroclinpharm.com

Post Name: Executive/ Sr. Executive - CTSM

Qualification: The incumbent should be a Science graduate with at least two to three years of experience working in a warehouse.

The core responsibilities for the position would be the following:

• Coordinate and manage all inbound and/or outbound activities relating to shipments of investigational products/ medical devices/non-IP materials pertaining to the projects allocated. Ensure that all shipments adhere to FDA guidelines, SIRO SOPs and Sponsor instructions.
• Keeping accurate records of the entire inventory stock in the warehouse relating to the projects allocated. To manage, maintain, update and ensure all accuracy for all records, files, material, inventories and actual stock count.
• Track the shelf life of all inventory and take Sponsor/PM approval for extendion of expiry date, wherever applicable.
• Coordinate with Project management team /Courier Companies for timely receipt of CTS acknowledgement receipt/transit temperature data for allocated project
• Review temperature files of storage areas
• Ensure calibration of all equipments and storage areas in accordance with SIRO SOPs.
• Coordinate with vendors, courier companies etc. for effective functioning.
• Coordination for renewal of AMC, vendor agreement.
• Coordinate with Sponsors , destruction companies, concerned project managers for destruction of expired medications.
• Maintain and record appropriate storage conditions relating to temperature, humidity and other applicable conditions
• Maintain good housekeeping of the warehouse and implement safety, security, housekeeping, and sanitation programs.
• Ensure arrangements to protect CTSF from damage due to fire/water/pests/any other hazards in accordance to SIRO procedure and inform administration at the earliest in the event of any condition (foreseen or otherwise) that may pose a risk to the safe and appropriate storage and movement of CTS and the safety and normal functioning of CTSF.
• Liaise with SIRO project management/ sponsors/ investigators as appropriate to ensure the safe and appropriate movement and storage of CTS.
• To undertake any other duties assigned by superior from time to time.

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Mail your resume to: hr_india@siroclinpharm.com

Opening for the post of Clinical Team Leader at SIRO Clinpharm, India

Company Name: SIRO Clinpharm

Company Website: http://www.siroclinpharm.com

Post Name: Clinical Team Leader

Qualification: The incumbent should be Doctorate/Master's/Bachelors Degree in Science with minimum five years of experience on Phase I/II/III trials is must in independent monitoring out of which one year of experience should be in line management working in CRO or a bio-pharmaceutical company. Basic understanding of the drug development process and understanding of clinical research process and ICH GCP is must.

The core responsibilities for the position would be Site Monitoring:

• Manage and direct the efforts of Sr. CRAs/CRAs/CTAs and recommend personnel actions including, but not limited to performance management, scheduling and work assignments, disciplinary action, promotions etc.
• Define and communicate job descriptions, core competencies, and performance standards and expectations.
• Assist in the development and implementation of reward and recognition programs in order to achieve optimal employee satisfaction and retention.
• Coordinate regular team meetings (at least with the frequency of two meetings per month) and ensure team is kept abreast of departmental and organizational activities, goals, and policies.
• Establish accurate and consistent productivity expectations and revise as needed.

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Mail your resume to: hr_india@siroclinpharm.com

Opening for the post of Executive – Medical Monitoring and Pharmacovigilance at SIRO Clinpharm, India

Company Name: SIRO Clinpharm

Company Website: http://www.siroclinpharm.com

Post Name: Executive – Medical Monitoring and Pharmacovigilance

Qualification: The incumbent should be an MBBS.

The core responsibilities for the position would be Safety and Medical Monitoring:

• Preparation of safety monitoring Plan in accordance with SIRO/applicable Standard Operating Procedures (SOP), Good Clinical Practice and local (Schedule Y) or applicable international regulations.
• Preparation of safety presentation for the investigators' meeting (IM) and for Site Initiation Visit (SIV). Making presentations at the IM.
• Preparation of Serious Adverse Event form as per the study protocol considering the template of the adverse event form and the SAE reconciliation plan.
• Generation of Periodic SAE listing and its submission to the Sponsor, sites and regulatory authorities and follow-up with monitor for ethics committee acknowledgments.
• Preparation of Annual safety update report as a part of Annual status report of the project to be submitted to the DCGI.

For more details: Click here

Mail your resume to: hr_india@siroclinpharm.com