Merck Sharp & Dohme | Associate Director - Reporting, ...

Job Description Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. RESPONSIBILITIES: Develops career plans for direct reports aligned to GDMS organization's goals and provides developmental opportunities through the following methods: Identifies challenging growth assignments. Coaches for performance attainment in addition to communicates timely frequent feedback to support growth. Performs periodic skill assessments evaluations as well as leads annual performance appraisals. Shares rewards and recognition where appropriate. Facilitates team priority setting in addition to individual priority setting. Ensures direct reports receive appropriate training and mentoring. Develops promotion strategies and prepares promotion recommendations. Possesses innovative mindset focused on continuous improvement and operational efficiency within team in addition to cross-functionally. Displays collaborative approach in problem solving, governance, change management and appropriately synthesizes key business information to management where appropriate. Identifies, facilitates, and directs work assignments aligned to resource availability and constraints. Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports value-added work and work-life balance, estimating length and difficulty of tasks and projects, anticipating, and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level. Participates in the recruitment, interview, candidate selection process in addition to performance improvement plan/termination as necessary. Assumes specific functional leadership responsibilities for business deliverables assigned to direct reports or supervised staff on project. Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts. May serve as a functional area head with responsibilities for determining Standard Operating Procedures and other business practices for that area (including management of an operating budget). Determines, collects, and interprets performance metrics. Identifies correction strategies and ensures they are implemented accordingly. Manage performance. Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations. Stays current in technology and regulatory changes both within and outside of our companies that may impact staff. May participate in or lead initiatives beyond GDMS (e.g. cross-divisional projects, cross-industry initiatives, etc.) May support any other project or perform any other data management or drug surveillance task deemed appropriate by management. May supervise contingent, non-exempt, or temporary workers, onshore and offshore. Education: At least B.A. or B.S. degree in relevant discipline. Knowledge and Skills: Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry experience preferred, at least 3 years of supervisory or management experience. Strong knowledge of Clinical Development through submission Process, ICH, GCP guidelines and CFR 21 regulations related to Clinical Development and Technologies. Must understand the technology landscape of the Clinical Development and integrations of the different solutions. Knowledge of database structures and available tools to manage, extract, and report data, general Technology aptitude. Ability to find innovative and sustainable solutions to people, process, technology, and organizational issues. Ability to adapt to constantly changing environment and to be able to contribute to the change as well. Ability to work collaboratively with other functional areas, divisions, and vendors. Ability to synthesize information from multiple sources, provide cohesive response, identify optimal path forward and communicate to management in clear, and concise manner and any actionable items. Strong organizational, time management, problem solving and project coordination skills. Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas. Strong sense of urgency and leadership abilities. Ability to present in a group environment. Ability to lead a team. Ability to be flexible, multi-task and work independently. Basic knowledge of statistical concepts. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Job Posting End Date: 11/25/2024 #J-18808-Ljbffr

Created: 2024-11-26