Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts. Aurigene has pioneered a unique, collaborative business model to work with pharma and biotech partners, in a win-win partnership that combines Aurigene’s deep expertise in oncology and inflammation, with our collaboration partners’ needs for expertise, scalability and high-quality, quick and cost-effective prosecution of targets.
Post : Group Leader/Sr. Group Leader/Assoc. Dir. - Clinical Operations
Job description
- Oversee all operational components of clinical development for early stage clinical projects in partnership with relevant functions, CROs, vendors, and external corporate partners, as applicable
- Develops and maintains the clinical trial operational plans including timelines, budgets, and resource requirements within a therapeuticarea
- Develops and constructs content for risk mitigation plans to ensureclinical trials are on time and within budget
- Implements clinical trial operational plans ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budget
- Reviews and contributes to Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs),
- Pharmacy Manuals, Laboratory Manuals from an operational perspective
- Leads CRO/vendor selection process for outsourced activities, including development of RFPs, scope of services agreements, budgets, study
- plans and timelines
- Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications
- Reviews invoices for accuracy compared to operational plans, budgets,and work known to be performed by CRO/vendor
- Manages CRO/vendors to achieve goals and ensures that performanceexpectations are met
- Participates in patient identification activities and the development ofpatient recruitment plans and back-up plans
- Identifies, recruits, and approves clinical investigators in collaborationwith Medical Monitor and Clinical Operations leadership
- Ensures that all supportive study-related documents are completed(e.g. Monitoring Plan, Study Reference Manual, Laboratory Manual,Pharmacy Manual, CRF Completion Guidelines, etc.)
- Ensures that all monitoring activities and processes are complete,including training of internal and external resources, and are compliantwith internal company SOPs and GCP/ICH/regulatory guidelines
- Recommends and implements innovative process ideas that impactclinical trials and/or clinical program managemen
- Participates in the development of clinical operations quality systems,including SOPs, document management, clinical operations personneltraining, and quality control processes
Candidate Profile
- 4+/6+/8+ years of prior operational experience in coordinating & managing clinical trials in India & globally across regulated markets.
- Capable of interacting effectively with scientists and managers within and outside the organization
- High level understanding of the clinical study implementation process with emphasis in therapeutic indications including oncology and inflammation.
- Strong understanding of GCP, CFR and ICH guidelines with good
- understanding of the regulatory (eg, FDA) auditing process
- Strong understanding of relevant regulatory health authority expectations and regulations as it relates to early clinical developmentand experience of having interfaced with such agencies.
- Significant experience in clinical trial budgeting, vendor/CRO ID, contracting and project management.
- Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems),processes and SOPs
- Experience in managing and leading meetings with the clinical trialteams, experts, investigators etc.)
- Ability to work in an international environment with internal and/orexternal partners
- Proven ability to apply broad multi-disciplinary expertise to problemsto arrive at innovative strategies and solutions to support clinical development objectives.
- Demonstrated management and leadership skills in a matrix environment; Can influence decision making with internal stakeholders,customers and collaborators.
- Excellent oral and written communication skills
Additional Information:
Qualification: Masters degree in life sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Other
Location: Bangalore, Karnataka
End Date: 30th April, 2017
Send your application to careers@aurigene.com.
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