Senior Mаnager Clinical Operations, FSP

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

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 to 0 to 5 years).
• 5+ 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 the requirements of the role.

SUMMARIZED PURPOSE:

Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for respective staff, which may include CAS, CS, CRAs, RSMs, PAs (if applicable) and/or other clinical operations focused staff. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members assigned to any monitoring modality and/or environment (i.e. FSO, FSP, Government, etc.). Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company’s SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

ESSENTIAL FUNCTIONS

• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations.
• Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Ensures understanding and facilitation of the risk based monitoring approach.
• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
• Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

MANAGEMENT ROLE:

Directly supervises individual contributors, administrative support and / or entry-level professionals
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.co