Manager, Clinical Research
Location: Parsippany New Jersey
Description: Ferring Pharmaceuticals, Inc. is currently interviewing Manager, Clinical Research right now, this career will be placed in New Jersey. Detailed specification about this career opportunity please read the description below. Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innov! ative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base, with over 3,700 employees worldwide, it operates subsidiaries in over 45 countries and makes its products available in more than 70 countries.
Ferring US development organization of Ferring Pharmaceuticals, Ferring International Pharmascience Center U.S. Inc (FIPCUS), develops new groundbreaking medicine that can enhance the quality of life for people. To sustain this effort, we reward talent with influence. In return, we expect our employees to be people of ambition.
The Manager, Clinical Research is responsible for managing the operational aspects of multiple studies from the planning stage through trial execution, concluding with the locked database and the completion of the Integrated Clinical Report; managing the clinical research associate staff assigned to the! study; and supporting the Therapeutic Area Head. The individu! al will be required to have Technical, Leadership, and Interpersonal Competencies.
1. Participate in the development and coordination of protocols, informed consent forms, investigator brochures, clinical study reports, and other documents, as well as assist in the updates of IND annual reports, to ensure a thorough understanding of the goals and objectives of the proposed study
2. Manage the operational conduct of single and multicenter studies , including vendor and site selection, development of CRFs, monitoring plan, communication plan, site budgets, and investigator meeting. Present at investigator meeting. Develop study-specific tracking tools and systems as well as manage timelines, study budgets and communicate progress to Director of Operations.
3. Effectively manage and motivate the clinical staff (e.g., clinical research associates, administrative assistants) assigned to the study in order to meet study objectives.
4. Manage th! e needs of a study by working alongside the Medical Director and assist the Vendor manager in contract negotiation and vendor selection includes activity and communications with various clinical and functional departments.
5. Maintain relevant FIPCUS internal tracking systems, including all clinical study management systems, PRONTO and REAL by communicating with and obtaining input from the individuals and departments involved.
6. Review and approve all study expenditures and bills, coordinating with the accounting department. Ensure decisions are made according to plan as well as managing the budget for that particular study.
7. Maintain ongoing communication with with the Medical Director toFIPCUS management regarding study progress, enrollment, and any problems encountered during the study. Trouble-shoot throughout the course of the study to resolve any issues arising at study sites, or with monitors and CROs.
8. Travel to sites and ot! her Ferring facilities as required.
9. Ensure that the conduct! of all studies follow local or global Ferring SOPs and regulatory requirements.
Develop, negotiate and track study budgets and contracts including those pertaining to: CRO, Lab vendor, Sites, other miscellaneous vendors
QUALIFICATION REQUIREMENTS:
A minimum of a bachelor’s degree is required. Advanced degree preferred.
Must have an in depth understanding of the drug development process as well as the operational and regulatory aspects of clinical development. Understanding if ICH GCP guidelines and sponsor responsibilities.
A minimum of seven experience in the pharmaceutical industry is required.
Must have extensive experience with vendor management, CRO management and process.
Experience with study start-up, time management, knowledge of study expenditures is required
In-depth knowledge of the protocol development . Experience with capturing relevant data in EDC format. Knowledge of edit checks, w! riting and answering queries.
Knowledge of study expenditures. Understanding of budget negotiation, milestones and penalties.
The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Ferring Pharmaceuticals, Inc..
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This career starts available on: Thu, 28 Mar 2013 05:29:36 GMT
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