At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an open, flexible and challenging work environment, which allows for rapid career progression.
Post : Sr Clinical Trial Associate
Job Description
JOB SUMMARY:
The Lead Clinical Trial Associate Lead (LCTA) will support the project team by performing a variety of physical and administrative tasks that aid in the execution of the clinical trial. Areas include (but are not limited to): managing, handling and distributing Clinical Trial Supplies and maintenance of tracking information, updating and maintaining information within clinical systems, creating and maintaining Trial Master Files (TMF - paper and electronic) including periodic review for accuracy and completeness, preparing and handling documentation and reports; track and manage Case Report Forms (CRFs), queries and clinical data flow. The LCTA provide supervisory support of other CTA’s.
Responsibilities:
• Oversee the day-to-day activities within the Logistics function and supervise other CTA’s.
• Works closely with the Director or Manager of the Logistics Function to ensure training of new CTA’s and may represent the function at meetings within and outside of Clinical Operations and Biometrics.
• Materials (supplies, binders, labels, etc.): Work with study teams to identify specifications and develop study related materials to those specifications working under minimal oversight. Prints labels for all types of materials.
• Receiving: Receives, inspects and inventories Clinical Trial Materials (binders, labels, kits, reagents, consumables) insuring appropriate quality, quantities and storage conditions (warehouse, coolers, freezers, etc.), completing relevant documentation as necessary, establishing electronic inventory records, and communicating with Clinical Teams.
• Material Management: Maintains electronic and physical inventories of Clinical Trial Materials, relabels marketed products for investigational and/or research use as necessary, tracks expiraton dates.
• Picking / Packing / Shipping: Follows moderate to complex instructions from Clinical Team to fill shipping requests of Clinical Trial Supplies and/or Samples insuring accuracy of items and quantities, appropriate packing materials and shipping conditions (e.g., frozen, refrigerated and ambient), as well as shipping instructions to insure compliance with all DOT, IATA, and local and federal regulations.
• Creates, maintains and audits Trial Master Files (TMF - paper and electronic), including interacting with internal and external study team members and investigator staff for collecting and managing related study documents.
• Establish good working relationships across all Life Cycles and Faciilities groups to effectively deliver work objectives.
• Accurately and effectively communicate services / capabilities, needs, issues, material inventories, and project status with all necessary groups and individuals (Manager / Supervisor, Study Teams, Facilities, etc.).
• Performs additional duties as requested by manager or designee.
Candidate Profile
- Bachelor’s Degree required or equivalent combination of education and work experience.
- Clinical Trial Support experience in Diagnostic, Medical Device, and/or Pharmaceutical industry preferred
- 4 – 6 years of related experience minimum, 6+ years of industry experience preferred
- Warehouse / hands-on material management experience required
- Trial Mater File / electronic Trial Master File management experience required
- Supervisory experience preferred
- Supervisory / people leadership skills
- Able to communicate clearly and accurately both written and spoken in English
- Strong customer service orientation
- Self-motivated and displays initiative
- Advanced knowledge of clinical trial processes and regulatory requirements in Diagnostic, Medical Device, and/or Pharmaceutical industry, including GCP and ICH guidelines
- Able to understand and follow detailed and complex work instructions
- Attention to detail and accuracy in work.
- Effective time management and organizational skills.
- Experience with inventroy management and using copying / printing equipment
- Stong computer skills including proficiency in using Microsoft Word, Excel and PowerPoint.
- Problem solving skills and demonstrated project delivery
Additional Information:
Location: United States, Arizona, Tucson
Qualification : Bachelor’s Degree
Industry Type: Pharma
Functional Area: CTA
End Date: 15th May, 2018
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