Job Title: Manager ISIS (Submissions and Investigator Services)
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Vacancy details
Vacancy description:
Job Code:
ROISIS
Job Title:
Manager ISIS (Submissions and Investigator Services)
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
Romania
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
31 Jan 2009
1. PURPOSE OF THE JOB:
• To coordinate and manage the start up activities of individual studies and staff in a manner that ensures timeline and quality targets are met.
• Maintain a clear overview of regulatory developments. Monitor, identify and implement new regulatory strategies and requirements.
• To ensure all start up activities follow the relevant ICON and regulatory guidelines and procedures
• To provide expert regulatory input into new business proposals and bid defense meetings
• Ensure that ISIS data base needs and metrics are completed on time and correctly
• To effectively manage assigned staff to ensure high performance, continuous development and low turnover.
• Maintain relationships with regulatory authorities.
• Professionally represent the ISIS group to internal and external customers. Manage site audit inspections by regulators and customers. Negotiate with customers and regulators as required
• Develop job-specific training requirements, associated curricula and documentation and identify training needs of ISIS departmental staff while ensuring consistency with ISIS and ICON standards.
• Maintain up-to-date knowledge on regulatory requirements in their regions(s)
• Identify and set objectives. Globally lead the ISIS staff in their regions to achieve personal, departmental, business objectives and key performance indicators. Perform line staff performance reviews. Manage a global team
• We expect all ICON employees to recognize and live ICON's values which centre around our commitment to People, Clients and Performance
• Recruitment and selection of staff for the department.
• Highlighting the training needs and developing the teams’ goals.
• Process development and implementation
• Development of senior members of the team and delegation of tasks to them.
2. JOB FUNCTIONS/RESPONSIBILITIES:
• Manage assigned studies in a timely manner in adherence with ICON SOPs, ICH, ISO, GCP and other regulations and liaise with other department managers as necessary to achieve this.
• Identify and implement appropriate compliance and regulatory strategies to facilitate in the efficient and effective delivery of submissions and cost effective processes
• ISIS Process development and implementation
• Interact and cooperate with Managers from other regions to improve ISIS process and business performance
• Work effectively with colleagues to participate and contribute to the setting of company wide quality objectives. Support all departments to ensure continued compliance with ISIS and ICON objectives
• Coordinate/allocate ISIS team members and submission activities for assigned studies
• Issue resolution activities
• Develop and maintain an effective interface with user groups to facilitate compliant and improvement focused operations and systems.
• Develop and maintain relevant ISIS study documentation including internal and external communication plans.
• Manage start up activities in accordance with the contract. Proactively recognize any changes in scope and collaborate with Business Development (BD) and Clinical Operations to ensure timely completion of change orders.
• Implement Quality Review procedures and monitor quality metrics to ensure a high quality standard is maintained throughout the study start up activities.
• Act as the key client contact for designated start up and develop successful working relationships with clients to help secure repeat business.
• Ensure all necessary training is provided to assigned staff to improve their job performance and knowledge. Provide coaching/mentoring, as necessary. Implement individual development plans and ensure training is documented, as appropriate.
• Effectively manage staff through open and timely sharing of information, regular performance review and feedback, and setting clear goals and objectives. Ensure individual and team achievements are appropriately recognized.
• Develop a succession plan and, in the event of a change to the team, ensure a thorough and effective handover which is appropriately documented.
• Ensure all management/tracking systems are up to date and monitor workload for assigned ISIS Associates. Pro-actively flag potential resource issues to Regional ISIS managers/ISIS Director.
• Provide regular feedback to ISIS senior management on study start up status, client satisfaction and staff issues.
• Participate in interviews, as required.
• Maintain confidentiality of management information, as appropriate. Participate in business development activities, as appropriate.
3. QUALIFICATIONS/EXPERIENCE REQUIRED:
• Background in medicine, science or other relevant discipline and appropriate experience.
• Ability to develop methods, techniques and evaluation criteria in a regulated environment, consulting senior staff as necessary.
• Thorough knowledge of regulatory and EC submission requirements in relevant countries.
• Thorough knowledge of ICH, ISO, GCP and other relevant regulations for the conduct of clinical trials related to pharmaceuticals, biologics, medical devices, and combination products.
• Good understanding of project management processes.
• Business acumen
• Highly developed problem solving skills and strategic thinking
• Strong people management and effective communication skills.
• Good commercial awareness and customer focus.
• Fluent in written and spoken English. Additional language skills desirable.
• Computer literate.
• Current full driving license.
• Ability and willingness to travel at least 35% of the time (international and domestic; fly and drive).
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