Mgr, Study Start Up & Regulatory

Job Description

*Manager, Site Start-Up & RegulatoryCome discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.Job responsibilities Conducts people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Provides guidance on administrative policies and procedures, technical problems, priorities, and methods. Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Supports management with site start-up or maintenance and financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams. Interacts with the executive management and Legal Department and assists with the accurate creation and implementation of site contracts, site start-up, maintenance and regulatory management workflows. Identifies and reports on areas of process and risk. Implements customer-required and/or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager; may supervise a systems administrator. Develops requirements for modifications to existing systems and reports based on input from functional teams. Provides input and requirements for long-range IT plans. Implements Company and customer-required project management systems and processes. Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times. Oversees all quality control efforts of individual departmental teams. Represents the Company at professional meetings or seminars. Establishes and maintains training materials for assigned area, *What we re looking for Bachelor s Degree. Experience in a clinical research organization and related contract management or site start-up experience. 7+ years of working experience in India Study Start Up related operations, Submission,Regulatory Submissions , ICF submission, IRB related activities.Background in development/management of information systems and process engineering preferred. should have 2+ years of working experience in Lead/Supervisor/People Manager role Strong presentation, documentation, and interpersonal skills. Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment. Demonstrate line management abilities. Strong leadership skills; ability to teach/mentor team members. Ability to coach employees to reach performance objectives. Ability to recognize and take appropriate action when employee performance is not acceptable.Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Keyskills :
audio masteringms officestandard operating proceduressubject matter expertsproject reviewsamericans with disabilities actline managementms projectquality controlenterprise project management