Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees. May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Job Knowledge A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Supervision Received Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Business Relationships Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with complex/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision making skills Effective oral and written communication skills, including English language proficiency Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial Acument and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc