Clinical Research Manager
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POST DATE 8/11/2016
END DATE 12/19/2016
Medical Devices & Diagnostics Company
JOB DESCRIPTIONCLINICAL RESEARCH MANAGER - TX - #2274
As a world leader in medical technology, our client offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery. They are a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites. They are currently searching for a Clinical Research Manager in the Austin Texas area.
KEY DUTIES, ACTIVITIES AND RESPONSIBILITIES:
The CLINICAL RESEARCH MANAGER is responsible for all aspects of clinical study operations for assigned company clinical projects according to the strategy defined by leadership of the firm's Global Clinical Affairs team.
* Coordinates clinical operations including: Design, initiation, coordination of clinical trials to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Leads CRO evaluation and selection process, and provides ongoing CRO oversight.
* Coordinates the preparation of state-of-the-art study documentation, including: protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
* Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP, FDA regulations and any other applicable local/international regulatory requirements.
* Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members.
* Responsible for the financial management of the clinical trial program including budget planning, resource allocation preparation of quarterly reports and investigator payments as applicable.
* Plans and manages study site activities and provides ongoing updates of site status to management.
* Supports data collection, assessment and reporting activities. Works closely with Data Management for the design and execution of appropriate data management practices, including the use of electronic data capture (EDC), and clinical trial management systems (CTMS).
* Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications.
* Anticipates/identifies potential problems and implements corrective actions on clinical trials.
* Participates in quality improvement efforts to increase overall operational efficiency of the clinical operations team.
* Interfaces with Global Clinical Affairs, Legal, R&D, Marketing and Sales to ensure that clinical activities are in line with overall strategic goals.
* Supports regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies. Collects, reviews and tracks regulatory documents when required.
* Represents the company at conferences, regulatory meetings, and relevant trade associations.
* Accurately completes administrative activities in a timely manner.
* Ability to travel 20% to 50% of time.
WORK EXPERIENCE, SKILLS AND EDUCATION REQUIRED:
* Master's Degree (or equivalent) in Medicine, Life Sciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus.
* Five to seven years' experience in clinical research required, preferably in medical device industry. Proven track record of conducting successful clinical research studies in China for a medical device and/or pharmaceutical company, or CRO.
* Manages local clinical research staff to support and achieve department objectives.
* Strong interpersonal, verbal and written communication skills. Native speaker in Mandarin, full professional proficiency in the English language (spoken and written).
* Ability to form strong and constructive internal as well as external professional relationships.
* Detail oriented, excellent organizational and management skills.
* Position requires composition ability, and a proven track record of the following: data analysis and statistical skills, scientific writing and presentation skills
* Experience in applied science, leadership skills and ability to merge science with business goals preferred.
* Expert in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies. Thorough knowledge of CFDA guidelines and local regulations concerning clinical research, as well as ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials.
* Experience in scientific literature searches, retrieval and evaluation. Authorship of peer reviewed scientific journal articles is preferred.
* Experience in the use of electronic data managements systems.
* Experience in collaborations with relevant trade organizations, as well as hospitals and physicians.
* Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level.
* Must be computer literate with working knowledge of Microsoft Office.
* Project management certification or relevant experience is a plus.