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Clinical Operations Manager - USA

Employer
Simbec-Orion
Location
Homeworking, USA
Salary
Competitive
Start date
25 Oct 2021
Closing date
16 Nov 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

Summary of the Position:

We are looking for a Clinical Operations Manager to join our Clinical Operations department. You will be based remotely in the USA.

You will manage a team of Clinical Operations employees and will support them in the execution of Clinical Studies and will ensure adequate resourcing on studies as per agreed budget. and pro-actively recruit additional personnel based on departmental needs. You will assume responsibility for the direct report's role in monitoring such that subjects' rights, safety and wellbeing are protected, trial data are reliable, and study timelines are met. Involvement in direct communication with sponsor and clients, where appropriate.
You will support the day-to-day management of the Clinical Operations department and create an environment where employees can grow and develop in their role.

Key Accountabilities:
  • Line management of Clinical Operations Employees (CTA, IHCRA, CRAs, CTL).
  • Ensure adequate resourcing is available for clinical studies as per the agreed budget ensuring that vacancies are filled within the department and playing an active role within the recruitment process.
  • Ensure appropriate onboarding of staff, provide training and support throughout for the direct reports.
  • Responsible for maintaining high-quality standards across the department as set out in Simbec-Orion SOPs and ICH-GCP regulations.
  • Ensure compliance is maintained by employees by performing spot-checks of visit reports, completion of clinical trial systems and timely TMF filing.
  • Perform Accompanied Visits with direct reports to assess performance and develop improvement plans to create a culture of continuous development.
  • Management of administrative aspects of Line Management (Timesheets, expenses, etc.)
  • Contribute to SOP updates and process improvements for the Clinical Operations Department.
  • Involvement in direct communication with Sponsors and Clients, where appropriate, such as client calls, Bid Defence and Governance meetings
  • Close communication with key departments (i.e. Project Management, Medical and Regulatory Affairs, Biometrics and Quality Assurance) to ensure the smooth running of clinical studies

Minimum Requirements:

Essential:
  • Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
  • Experience as a Clinical Research Associate III or Clinical Trial Lead
  • Line Management / mentoring experience
  • Excellent communication skills
  • Proficiency in written and spoken English; fluent in host country language
  • Expert knowledge of relevant clinical research regulations and ICH-GCP
  • Ability to establish/maintain good relationships with sites/colleagues/clients
  • Ability to make decisions independently / Strong problem-solving skills
  • Highly developed mentoring and motivational skills


Desirable:
  • Advanced degree (Masters, MD, PhD)
  • Previous CRO experience
  • Good experience in CTMS, eTMF IXRS and EDC systems
  • Strong presentation skills
  • Competent in clinical trial planning and metrics management
  • Experience in multinational trials
  • Multiple therapeutic experience


Job Profile - Clinical Operations Manager.pdf


Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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