北京招聘

Description

Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.

If that is your passion, we have a place for you.

Title: Associate Medical Manager

RESPONSIBILITIES
• Monitors, evaluates and analyzes laboratory results on a daily basis, excluding weekends and holidays, from sponsordesignated
central laboratory using sponsor-designated data management system. Laboratory safety parameters are
monitored for each patient at every site throughout clinical drug trial.
• Conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using
relevant clinical laboratory experience. Follows established procedure for comparing current results with prior laboratory
values to evaluate or note potentially clinically significant increases/decreases, contacts the investigator site for pertinent
additional clinical assessment, consults with the Sponsor/Quintiles physicians for medical evaluation of case as needed.
• If applicable, reviews and evaluates retest results, initiates contact with investigative site if appropriate.
• Composes telephone contact reports documenting site contact that includes all clinically relevant information. Distributes
according to scheme designated at project inception.
• Responsible for training and serving as mentor for other Medical Services staff within the department.
• Serves as liaison between the Medical and Scientific Services Department, Quintiles Laboratories or other sponsordesignated
laboratory, and the Quintiles Project Team.
• Provides training for new hires and junior laboratory surveillance staff.
• Sets up new projects and project-specific procedures working in conjunction with the Sponsor/Quintiles physicians,
Quintiles Laboratories or other central laboratory Project Manager and Clinical Team Project Manager. Ensures that final
set-up is reviewed with the Sponsor/Quintiles physicians prior to study start-up. Ensures that set up is consistent with
Protocol specified objectives and helps maintain integrity of laboratory support services. In consultation with the
Sponsor/Quintiles physicians, suggests modifications based on identification of possible protocol deficiencies.
• Trains project CRAs in use of central laboratory web-based laboratory report review database, if requested.
• Provides instruction to CRAs regarding laboratory monitoring procedures on both individual basis and as part of more
formal training sessions.
• Attends investigator/study start-up meetings as requested by Sponsor and/or Quintiles physicians. Provides Medical
Services presentation at Study Start Up meetings as requested by Sponsor and/or Quintiles physicians.
• May review, evaluate and recommend modifications to designated central reporting specifications as requested by PM
and/or Sponsor/Quintiles physicians.
• Attends business development presentations as requested and presents laboratory monitoring capabilities of Medical
Services.
• Trouble-shoots remote data access problems with appropriate central laboratory personnel. Proactively alerts IT and
central laboratory personnel to data reporting issues.
• If utilizing Quintiles Laboratories QNET database, may provide interim data analysis of laboratory value trends/profiles in
graphic or narrative form at Sponsor, Clinical Team and/or Quintiles physician request.
• Represents Medical Services Team at client meetings, project team meetings and investigator meetings.
• Maintains up-to-date laboratory knowledge via continuing education activities (i.e., completion of continuing education
class, applicable QU courses, review of journal articles) or attendance at medical seminars.
• Based on clinical laboratory experience, identifies potentially significant trends or shifts in laboratory results and alerts
Sponsor/Quintiles physicians.
• Interacts with Project Team to convey critical information that may impact study objectives. Verifies site performance and
communicates information to Project Team and Sponsor/Quintiles physicians.
• Interacts with the designated central laboratory to ensure reporting of subject laboratory results is consistent with protocol
requirements.
• May participate in various Pharmacovigilance procedures including the processing of Adverse Event (AE) reports through
tracking, data entry, quality control, report generation and submission, records management, as well as other projectrelated
and system support tasks.
• May perform CEVA (Clinical Event Validation and Adjudication) project tasks in the areas of endpoint adjudication
committee coordination, core laboratory coordination, DSMB administration, and Steering Committee administration.
• Line management of assigned medical surveillance staff.
• Supervises Medical Surveillance Associates, Medical Surveillance Specialists, and Senior Medical Surveillance
Specialists.
• Evaluates medical surveillance workload and creates volume projections in order to ensure appropriate balance of project
assignments such that utilization rates are maximized for each staff member.
• Participates in HR hiring process including review of potential candidates and interviewing process.
• Participates in the mentoring and training of more junior medical surveillance staff.
• Ensures compliance with Quintiles Core Operating Procedures and applicable Medical Surveillance Work Instructions.
• Identifies and records non-conformity with Company procedures and work instructions, and recommends and implements
corrective and/or preventative action.
• May be assigned to small, sub-projects and may perform other duties assigned by line management.
• May participate in development of Medical and Scientific Services portion of client proposals including the budgeting
process.
• May participate in client presentations.
• Identifies ongoing training and development needs of staff.
• Assists Manager on variety of medical surveillance management issues including work instruction review.
• Recommends to Manager courses of action on all management and HR matters.
• Maintains up-to-date laboratory knowledge via continuing education activities or attendance at medical seminars.
• Maintains awareness of overall development in the field of clinical research, including application of new technologies, as
well as knowledge of assigned therapeutic areas, by reading related literature, attending professional meetings, etc.
• Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning,
assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining
employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
All responsibilities are essential job functions unless noted as nonessential (N).
Qualifications
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Knowledge of medical/scientific terminology. Strong technical ability to comprehend and integrate scientific data from a
variety of sources. Must have strong written and verbal communication skills. Ability to handle management and/or
personnel issues of low complexity. Ability to work independently and within a matrix team environment required.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Prefer BS, BA, or BTech in laboratory-related, science, or health care field and a minimum of 3 years clinical laboratory
experience or equivalent and an additional 5 years of medical surveillance or laboratory report review experience. At
least one of the years of required experience must be in a lead capacity. Prior supervisory experience preferred. PhD or
MD with a minimum of 5 years clinical experience. AA degree or equivalent in laboratory-related, science or health care
field and 4 years clinical laboratory experience or equivalent and an additional 5 years of medical surveillance or
laboratory report review experience; or equivalent combination of education, training and experience

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY