Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,400+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
About the Position:
The Senior Clinical Services Specialist develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications. Adheres to all relevant regulations including ICH and PhRMA guidelines and Allergan?s SOPs and policies.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
The employee will have strong computer skills, good organizational skills, ability to prioritize and a good understanding of clinical study costs.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
Clinical Study Specialist
Responsible for the logistical tasks associated with the preparation, collation and review of the regulatory documents submission package. Ensures distribution of draft essential documents to the selected sites. Responsible for drafting and reviewing of Study ICF. Responsible for the development of
the Country-specific Informed Consent template by adapting the Study ICF templates with country-specific requirements. Confirms the drug release documents are received in-house and follows-up with site if documents are missing or incomplete. Responsible for on-going regulatory document maintenance. Responsible for the preparation, review, confirmation and distribution of the draft Clinical Trial Agreement and Budget to Site. Responsible for the Negotiation with site on budget costs and contract language. Ensure follow-up with site if documents are missing or incomplete. Ensure the preparation of the final Clinical Trial Agreement and budget and route for signature. Ensure the distribution of final documents as appropriate. Responsible for managing amendments to the CTAs as
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan?s policies, SOPs and Work Instructions. Ongoing training in compliance
areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Other activities, special projects and assignments may be given as required.
* A Bachelor's degree in a science or health-related discipline.
* A basic understanding of contracts and negotiations is preferred.
* Either a Masters Degree with 2 years clinical research experience, or Bachelor's degree with 4 years clinical research experience.
* Working understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based).
* Working understanding of clinical study costs.
* Working knowledge of concepts of clinical research and drug development.
* Competencies and essential skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
- Apply at: http://hirelifescience.com/seeker_jobs.aspx?jobsID=476006&jobtitle=Sr.%20Clinical%20Services%20Specialist%20-%20RDCM