Manager, Clinical Operations - Full Service CRA Line Manager (Home-Based in Western US )

Description Manager, Clinical Operations - Full Service CRA Line Manager (Home-Based in Western US ) reputed company is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers reputed company their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a reputed company where everyone feels like they belong.

Job Responsibilities Core Responsibilities

• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling May be involved in assignment of project work and will review workloads for reputed company direct reports. Manages staff by establishing goals that will increase knowledge and reputed company levels, and by delegating tasks commensurate with reputed company level.
• Review workload for reputed company staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion.
• Provide expert operational reputed company and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively work to ensure staff retention and turnover rates remain reputed company expected levels.
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure reputed company staff follow required training and complete required documentation. Provide regular updates to management accordingly.
• Work closely reputed company appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements. May provide business development support.
• May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. reputed company and reputed company training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed.
• Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution.
• Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance reputed company in line with departmental goals and metric targets. reputed company reputed company quality control efforts of assigned teams.

Qualifications

• Bachelor's degree in life sciences, nursing degree, or equivalent reputed company experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership reputed company or equivalent combination of education, training and experience is required.
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements
• Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Strong time management, technical and organizational skills. Ability to work independently and reputed company a team environment.
• Knowledge of basic financial concepts as reputed company to forecasting and budgeting. Understands project budgets.
• Must demonstrate good computer skills and be able to embrace modern technologies.
• Ability to travel as necessary (up to 25%)

At reputed company, we reputed company in providing an environment and culture in which Our People can reputed company, reputed company and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with reputed company applicable federal, state, and municipal paid sick time requirements. Salary Range: The reputed company salary range represents the anticipated low and high of the reputed company range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.syneoshealth.com 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 reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.

Summary

Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site reputed company support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study reputed company Out. Provides training, consultation and oversees metric compliance and quality reputed company to operating activities of assigned staff to ensure project deliverables are met. Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with reputed company regulations. Supports senior management in operational level planning. May participate in business development presentations as a subject matter expert in Clinical Operations functions reputed company the Company. Apply tot his job Apply To this Job