Job Description

: Summarized Purpose: Effectively manages staff and related projects to deliver quality products in agreed timelines. Supports operational excellence and initiates improvements within the department. Mentors and develops staff encouraging their professional skills. Collaborates internally and with external clients. Works to resolve complex problems that meet client deliverables and needs. Essential Functions and Other Job Information: EssentialFunctions . Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management,coaching and mentoring, employee counseling, and separations. Approvescourses of action on salary administration, hiring, corrective action, andterminations. Reviews and approves time records, expense reports, requests forleave, and overtime (if applicable). . Directs the daily operations of the team. Fields questions from the team as wellas other departments and works to resolve complex problems ensuring thereview of multiple complex deliverables are organized and timely. Leads and/orcontributes to team meetings. . Serves as lead reviewer on large review projects. Collaborates with internal andexternal clients ensuring deliverables are met. Manages projects to deliverquality products in agreed upon timelines. Maintains knowledge and communicates current and updated guidelines and regulations to staff regardingclinical trials and document and/or other submission specifications. . Supports operational excellence by monitoring performance metrics to ensure aefficient processes. Initiates process improvements within the department byinfluencing processes and technology that drive the reviews. Participates andcontributes to meetings and activities. . Assists in the development, documentation and maintenance of business processes for document review through SOPs, WPDs and guides. 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 to5+ years). 1+ year of leadership responsibility 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 therequirements of the role. Knowledge, Skills and Abilities: . Ability to delegate tasks and facilitate completion of assignments . Effective management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workload . Demonstrated innovation in developing new ideas related to process improvements . Strong document and quality review knowledge . Proficient in Microsoft (MS) Word and MS Excel . Advanced organizational, analytical and interpersonal skills to manage several complex projects in parallel and manage rapidly changing priorities . Ability to independently assess client needs and work with project team members in producing compliant deliverables . Ability to independently learn new technologies . Advanced editorial/proofreading skills . Strong leadership to a diverse staff . Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables . Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

foundit