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Clinical Operations Manager
Company: INC Research
Hungary, Hungary
Ref: EP063-06
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About the Company :
| We are an organization composed of therapeutically-focused high performance teams led by world-class project managers and leaders, dedicated to helping our Customers bring products to market in order to improve world health |
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About the Job :
Clinical Operations Manager
Hungary
FLSA STATUS: Exempt
SUPERVISOR: Director, Clinical Operations
Provides management for all tasks and activities of the Clinical Research Associate and Clinical Research Specialist. Provides training and consultation related to operating activities for clinical trial projects. Serves as a resource to business development for new projects. Serves as a liaison with QA/SOP training. Identifies project and site related problems and works within the team to provide solutions.
ESSENTIAL JOB FUNCTIONS:
1. Responsible for the supervision of all Clinical Research Associates (CRA) and Clinical Research Specialists including recruitment, training, mentoring, work assignments, performance evaluations and discipline of assigned staff. Plans career development and assesses training requirements. Anticipates resource issues and plans remedial action. Assists with staff training and orientation for new employees. Assists in the development of adequate training programs.
2. Establishes quality and performance expectations for staff, and monitors staff performance on an ongoing basis. Maintains awareness of project issues, hours and overall workloads and advises Director of Operations accordingly. Ensures that project goals are met within appropriate timelines. Notifies Director of Operations when excessive hours are required to complete project timelines.
3. Ensures staff compliance to all Standard Operating Procedures and Work Instructions. Ensures that study-specific documents within the monitoring group are established, maintained current and followed. Assures all staff review revised SOP’s and assists with documentation of compliance.
4. Ensures that individual and work group/team tasks are completed according to country specific and government regulations.
5. Works closely with Project Management, Clinical Data Management, Biostatistics & Drug Safety, Quality Assurance and Regulatory Affairs to ensure quality performance on all studies as well as to correct process deficiencies as identified by INC staff, clients, and auditors. Provides coaching and motivation to staff when training or development needs are identified. Develops corrective action plan with the employee and identifies specific timelines for change based on achievable goals.
6. Assists project management and other functional departments with determining potential clinical trial costs, risk/benefit options, and complexity.
7. Organizes and chairs clinical staff meetings at regular intervals. Deals with issues raised or provides follow up for action items requiring resolution.
8. Works closely with LCRA to assure that site correspondence (visit reports, etc.), travel requests and expense reports for staff are submitted within project specific requirements and timelines.
9. Communicates with Senior Management and keeps them informed of activities/problems, etc.
10. Works closely with the Director of Clinical Operations in the allocation of monitoring resources. May serve as Clinical Project Advisor, Lead CRA, or assist with the study start up of new projects.
11. Provides support to Business Development on an as-needed basis by review of the clinical monitoring requirements contracted for the study (# days on site, # CRA’s required per study, etc.). Monitors clinical trends in the industry and recommends improvements to maintain a competitive advantage. May participate in marketing activities, client presentations and proposal development.
12. Monitors scientific and clinical development technology in therapeutic area of responsibility through literature, course work, meetings, professional meetings and associations and incorporates new technology, where appropriate.
OTHER RESPONSIBILITIES:
Performs other work-related duties as assigned
Demonstrates strong knowledge of the clinical development process
Demonstrates the ability to negotiate with outside investigators who are being considered for clinical trials
Demonstrates effective verbal and written communication skills
Demonstrates strong interpersonal skills
Able to manage interactions across diverse functions and projects, with special reference to sponsor’s expectations
Demonstrates the ability to work effectively in a team environment
Demonstrates the ability to effectively collaborate with all departments, (Biometrics, Project Management, Data Management, Regulatory Affairs, Quality Assurance)
Demonstrates the ability to effectively coordinate and interact with all internal and external personnel involved in conducting clinical trials
Exhibits the ability to plan and organize clinical trials within any therapeutic area.
Ability to remain flexible and adaptable in stressful situations
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Requires a B.S. or equivalent in a biological science plus a minimum of five (5) years experience in the pharmaceutical development field and a minimum of 2 years in a clinical project lead capacity or staff management experience. Basic understanding and usage of medical terminology is preferred. In-depth knowledge and experience with Good Clinical Practices (FDA and ICH guidelines) are essential. Prior supervisory experience is preferred. Requires effective presentation, documentation and leadership skills, as well as strong team-oriented and interpersonal skills. Excellent organizational and communication skills and ability to work independently and within a team environment is required. Ability to lead and motivate a group of associates is preferred. Strong computer skills in Word and Excel are necessary. Computer literacy (or a willingness to learn new programs) in additional software (e.g. Power Point, etc.) is preferred. A willingness to travel is essential.
PHYSICAL REQUIREMENTS:
Position requires extensive telephone and face-to-face communications, which require accurate perception of speech. Position also requires sitting for prolonged periods of time. Travel up to 50% of time is required. Position requires close vision, distance vision and the ability to adjust focus. The noise in the work environment is moderate.
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Profile of Ideal Candidate :
| Extensive knowledge of working within a CRO or Pharmaceutical company |
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