Senior Manager, Clinical Operations

United States
11 Jun 2021
11 Jul 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Senior Manager, Clinical Operations

Home-based (prefer TX but OH but not required)

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.

Position Overview

The Manager, Clinical Operations is responsible for the line management of assigned direct reports with responsibilities encompassing mentoring, development, training and performance review. Collaborates with senior management in the on-going development and management of staff in correlation with departmental objectives. This role is responsible for Line management and resourcing of Clinical Research Associates (12-18).

  • Mentor, coach, and train direct reports in applicable tasks, responsibilities and regulations. Ensure appropriate standards are met at all times.
  • Identify individual training needs; ensure compliance with required training as well as the timely completion of training records.
  • Discuss and plan career development with direct reports in an on-going manner; provide guidance and assistance wherever possible.
  • Ensure the consistency and quality of direct report performance: measure and report on Key Performance Indicators (KPIs); communicate with direct reports' project team(s) regarding input on performance; ensure issues and results of discussions are escalated appropriately to Clinical Operations senior management; manage and resolve performance issues.
  • Hold direct reports accountable for compliance with project plan(s), contractual obligations, applicable company CDs and ethical, regulatory and clinical standards.
  • Hold direct reports accountable for issue escalation to project teams, the Sponsor and QA, as appropriate.
  • Hold at least monthly one-on-one meetings with direct reports to monitor work load and performance, providing on-going feedback and recommendations for improvement and development.
  • Perform regular review of billable hours and utilization for direct reports. Escalate relevant issues to senior management.
  • Complete and deliver performance appraisals, as required. Communicate with Clinical Operations senior management and HR to recommend promotion and/or compensation adjustments.
  • Manage direct report time off requests, timesheet and applicable expense report approvals. Review of timesheet includes assessment of accurate recording of time as related to project assignments and tasks.
  • Participate in staff recruitment efforts through interviewing and selection of new clinical personnel together with HR.
  • Conduct onboarding activities; manage induction/orientation modules for new direct report(s) to ensure smooth assimilation to the company.
  • Maintain an awareness of and effectively communicate management strategies, policies and procedures in conjunction with leadership teams.
  • Maintain awareness of overall development in the field of clinical research to ensure that staff remains current on clinical monitoring developments.
  • Develop and maintain effective relationships with Clinical Operations management team to cohesively manage staff.
  • Coordinate and conduct departmental meetings as required. Develop and distribute agendas and meeting minutes.
  • Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.
  • May contribute to the development and revision of SOPs and standard plans/templates/guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
  • Liaise with internal and external customers in relevant process improvement initiatives; may assist with the creation and delivery of new department initiatives, improvement plans or training.
  • Conduct accompanied field assessment visits with CRAs as appropriate.
  • May collaborate with other department and /or functional groups to ensure consistency of processes.
  • May provide input to the Clinical Operations portion of proposals, budgets and contracts.
  • May support Business Development with preparation for and attendance at Client meetings e.g. Capabilities and Bid Defense meetings.


Academic & Professional Qualifications:
  • Bachelor's degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
  • 6+ years relevant experience, to include the demonstrated ability to provide guidance and direction to others effectively and/or demonstrated experience in clinical study management, monitoring, and in developing study-related documents.
  • Line management experience required

Skills & Experience:
  • In-depth working knowledge of current ICH-GCP guidelines and applicable regulations.
  • Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
  • Strong communication skills including effective verbal, written and presentation skills; English + local language, if relevant.
  • Strong leadership and interpersonal abilities and organizational skills in a complex and fast paced environment.
  • Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
  • Ability to mentor and train clinical staff.
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint.

This job excludes Colorado applicants.

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.