Sobre

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description Manager Amendment Implementation Summarized Purpose: Leads and manages a team of employees responsible for the successful completion of amendment implementation deliverables within assigned studies; May manage and/or serve as a mentor to junior managers or acting as the lead manager; Responsible for oversight and execution of amendments to ensure the achievement of departmental goals; Works with the resourcing team and other PSS people managers to meet resourcing needs and amendment implementation deliverables, determining strategy, using advanced negotiation skills when needed. Essential Functions: • Primary focus is on people and performance management of team members, with a secondary focus on operational management of amendment implementation • Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and policies • Serves as positive leadership and professional role model for all staff providing direct coaching and development support to their operational teams • Collaborates with management and executive staff in various Clinical Development Services Division (CDSD) departments (e.g. Project Delivery, Clinical Operations, etc.) on tasks, initiatives or workstreams of moderate complexity as required • Works in collaboration with the resourcing team, other PSS people managers and study managers to meet resourcing needs and amendment deliverables/milestones, determining strategy and using moderate negotiation skills when needed • Approves courses of action on salary administration, hiring, corrective action, and terminations • Reviews and approves time records, expense reports, requests for leave, and overtime • Ensures initiatives are implemented to ensure efficiency in proposed processes, consistency in execution and quality output • Performs any other duties and projects as assigned by leadership Education & 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), 1+ year of leadership responsibility Knowledge, Skills and Abilities • Solid knowledge of ICH GCP, applicable regulations and Company/Client procedural documents • Advanced knowledge in all phases of clinical trials, specifically study startup, study maintenance and study close out • Advanced skills in managing, engaging, motivating, mentoring and retaining staff • Strong knowledge of budgets, projects and metrics (financial and business acumen) • Ability to handle multiple tasks simultaneously, to meet rigorous timelines and to work effectively in stressful situations • Excellent organizational, strategic and negotiation skills and strong attention to detail • Excellent communication skills both written and verbal, including strong command of English, and excellent interpersonal and conflict resolution skills • Ability to travel if required • Ability to utilize problem-solving techniques applicable to a constantly changing environment Management Role: Manages experienced professionals and/or subordinate management who exercise latitude and independence in their assignments. 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, Abilities: • Demonstrated effective mentoring/leadership/supervisory ability including excellent interpersonal skills • Capable of motivating individuals/teams and proactively addressing and managing performance issues • Excellent clinical trials monitoring skills • Expert knowledge of relevant regulations and guidelines • Demonstrated ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology • Effective organizational and negotiation skills • Strong attention to detail • Effective written and oral communication skills • Good knowledge of English language and grammar • Competent use of computer to include data entry, archival and retrieval • Strong team player with team building skills • Strong interpersonal and conflict resolution skills • Utilize problem-solving techniques applicable to constantly changing environment • Proficient knowledge of medical/therapeutic areas Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Frequently drives to site locations and frequently travels both domestic and international. 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