Manager, Technical Operations

Job Category: Biotech/R&D/Science Career Level: Manager (Manager/Supervisor of Staff) Location: Waltham, MA 02451           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com PAREXEL is looking for a Manager, Technical Operations for our Waltham, MA office. The Manager's primary function is to provide direct project and team oversight. General responsibilities include supervision and management of staff; ensuring staff are trained, mentored and developed. Be responsible for the execution and productivity of data management activities on individual projects, ensuring adherence to regulatory and PAREXEL standards. Provide input to continuous productivity improvement. Ensure proactive planning takes place and provide issue resolution for the team. Key Accountabilities ' Provides a broad range of leadership and team building capabilities to achieve the Data Management objectives and goals. ' Working with other operational managers, take responsibility for managing technical activities either Data Management, including but not limited to database Set-up, Consistency check, import and export programming, and any ad-hoc programming required to support a clinical trial process. ' Provide technical leadership, resource management and project management for the required technical aspects supporting clinical trial activities. ' Create, direct and maintain strategies in line with the Data Management organization to help facilitate efficiencies within the department. ' Supervision of Clinical Programmers, Clinical Programmer Analysts, Senior Clinical Programmer Analyst and Principal Clinical Programmer Analysts. ' Lead cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trials. ' Identify and adequately resolve operational and technical problems. Manage process improvements. ' Communicate with the other operational groups regarding workflow, process, timelines, and resource planning to ensure transparency between the all functions as well as any external support groups. ' Define, develop and deploy appropriate operating procedures. ' Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations. ' Provide relevant training/mentoring for staff to assist them in resolution of problems encountered in the conduct of their daily work or on application of Clinical Systems. ' Co-ordinate the improvement and implementation of global tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies and quality. ' Participate on the Change Control board for the authorization of technical activities released for the development and production environments. ' Attend (as appropriate) client facing meetings to represent the Technical Operations group on activities including, but not limited to, progress reviews, technical updates on key milestones, bid defenses, technical requirements collection., ' Represent the Technical Operations group at internal and external audits and regulatory inspections, as required. Skills ' Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. ' Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement. ' Proven ability to work as a team player and ability to multi-task. ' Ability and willingness to make business decisions. ' Tenacity to work in an innovative environment. ' Effective communication skills that include provision of accurate information to stakeholders, proficient in English, strong written and oral communication skills, ability to work effectively with and motivate virtual teams. In addition, possess a strong cultural awareness. ' Ability to negotiate with respect and influence to achieve results ' Personal skills include ability to manage competing priorities, function independently, attention to detail, excellent organizational skills, flexibility to change and fulfilling activities to completion. ' People management skills include teamwork, ownership, initiative and reward. ' Business/Operational skills that include customer focus (internal and external), commitment to quality management and problem solving. ' Influencing skills including negotiation, problem solving and teamwork. ' Demonstrated ability to learn new systems and function in an evolving technical environment. ' Awareness of CRS software and tools, and ability to evaluate innovations. ' Demonstrated skills of working effectively in a quality-focused environment, and commitment to refine quality processes. Education: M.Sc/B.S./B.Sc./B.A. in a science or industry-related discipline Language Skills: Excellent English written and oral communication skills 5 or more years of relevant work experience recommended 2 or more years of Project Management or Management experience recommended (for intermediate level and above) RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2198429&boardid=749