Project Director, Clinical Operations

US-PA-Conshohocken Job posted on: 5/9/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! Job Summary • Serve as senior operational leader for one or more domestic and/or international projects for one or more clients, according to Covance Standard Operating Procedures, ICH Guidelines and GCPs . • In cooperation with Business Development, be the primary operational lead in the development and review of the strategies and associated cost estimates for proposals and to assist in the delivery at relevant client meetings (ex: Bid Defenses) as required. Review and approve strategy, content and costing. • Line management responsibility for the training, utilization, development and performance review of assigned personnel • Financial authority in accordance with the company approval matrix • Work with Senior Management to oversee the implementation of departmental initiatives and rollout of new departmental/unit/company policies Job Duties and Responsibilities • Evaluate progress of designated projects against timelines/ budget and client satisfaction surveys and recommend and/or implement appropriate action. • Establish partnership with assigned clients to ensure client satisfaction and operational excellence. • In cooperation with Business Development, be the primary operational lead in the development and review of the strategies and associated cost estimates for proposals and to assist in the delivery at relevant client meetings (ex: Bid Defenses) as required. Review and approve strategy, content and costing. • Promote effective teamwork among project team members within Covance departments and offices and external client team members. Effectively resolve conflicts as needed. • Provide performance feedback of team members to respective department Heads. • Ensure appropriate communication on departmental-related matters with Senior Management. • Ensure effective communication of company/departmental messages to Clinical Operations Group • Responsible for assisting in recruitment, training, development and performance reviews of assigned personnel • Involvement in detailed performance reviews and management of assigned staff, including appropriate management to resolution of performance issues as identified • Establish operational objectives and delegate assignments to assigned personnel • Supervise and monitor workload of assigned personnel to meet agreed timelines and budget. • Define and manage departmental resource needs and establish contingency plans for key resources; oversee recruitment, interviewing and onboarding of clinical operations staff • Meet resource management and utilization departmental targets for assigned staff and, in collaboration with the leadership of other functional groups, meet overall unit targets. • Ensure that all staff allocated within the department adhere to professional standards and SOPs established for clinical research. • Identify strategic training needs within the Clinical Operations Group and assist in the coordination and conduct of training and development efforts • Assist in developing, modifying and implementing company policies. • Participate in management of the clinical operating unit and initiate improvements to enhance the efficiency and the quality of the work performed. • Financial authority in accordance with current signature approval matrix • Perform other duties as assigned by management. Travel Required: • Available for domestic and international travel, including overnight stays. • Ability to drive and have a valid driver’s license. Experience: Experienced/Skills • Minimum of nine (9) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks. In lieu of the above requirements, candidates with > nine (9) years supervisory experience in a health care setting and six (6) years clinical research experience in the pharmaceutical or CRO industries will be considered. • Minimum of four (4) years of direct project management experience • Experience in managing projects in a multi-office environment. • Demonstrated ability to handle multiple competing priorities; utilize resources effectively. • Financial awareness and ability to actively manage financial tracking systems. • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system. • Demonstrated ability to lead by example and to encourage team members to seek solutions. • Excellent communication, planning and organizational skills. • Ability to work independently. • Ability to negotiate and liaise with clients in a professional manner. • Good computer skills with ability to understand and assess technology alternatives and implication for current processes. Education: Education/Qualifications Required: • University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). • Detailed knowledge of financial control procedures • Thorough knowledge of project management processes. • Thorough knowledge of time and cost estimate development. • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. • Fluent in local office language and in English, both written and verbal. • Broad knowledge of drug development process and client needs. Preferred: • Masters or other advanced degree. • Detailed knowledge of Covance and the overall structure of the organization. • Basic knowledge of Covance sales and business development strategies and procedures. • Thorough knowledge of Covance S.O.P.s • Knowledge of Covance training, human resource and performance appraisal processes. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |