Clinical Research Associate Manager - , DE | Biospace
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Clinical Research Associate Manager

AstraZeneca Pharmaceuticals LP

, DE
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Delaware,
United States
Job reference: R-012291

Posted date: Aug. 10, 2017

Clinical Research Associate Manager – Southern Midwest (TX, AR, OK, TN)

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Research Associate Manager, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Main Duties and Responsibilities

Direct functional line management of a group of Clinical Research Associates within US Site Management and Monitoring. Accountable for the successful execution of clinical trials including resource allocation, adherence to timelines and compliance with all SOPs, policies and regulatory requirements. Oversees project assignments, workload distribution and problem resolution with direct reports. Interacts with other team management and functions as needed.

  • Responsible for performance management and development including talent development, coaching, mentoring and providing routine feedback.
  • Interviews, hires, develops and trains staff on AZ SOPs, policies and procedures.
  • Communicates regularly with contract staff managers to provide feedback on contract staff performance.
  • Evaluates and projects resource needs on an on-going basis based on portfolio.
  • Ensures the implementation of clinical studies through efficient allocation of CRAs.
  • Ensures close working relationship within US SMM including other CRA managers and Clinical Research Managers as well as other key internal/external stakeholders
  • Responsible for ensuring adequate, timely and compliant monitoring, site management and oversight for assigned CRAs
  • Conduct regular (twice annually) quality visits with each employee CRA
  • Communicate with staff on program changes, policy changes, and priority shifts on a regular basis.
  • Be aware of issues affecting staff’s workload and efficiency. Collaborate with colleagues and US leadership team as needed for escalation and support for resolution.
  • Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies.
  • Conduct regular staff meetings and participate in Management staff meetings.
  • Leads special initiatives as needed.

nimum Requirements and Preferred Background

  • University degree in related discipline, preferably in life science, or equivalent qualification.
  • 10 years of clinical trial experience with at least 4 years of site monitoring. Study leadership and/or line management preferred.
  • Fluent knowledge of spoken and written English.
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge in relevant AZ Therapeutic Areas.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
  • Ability to travel required, approximately 15%.

    Next Steps – Apply today!

    To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

    AstraZeneca is an equal opportunity employer. AstraZeneca 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.


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