Clinical Study Manager - Gaithersburg, MD | Biospace
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Clinical Study Manager

AstraZeneca Pharmaceuticals LP

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

Job Description

Location:Gaithersburg, Maryland, United States
Job reference: R-006198

Posted date: May. 16, 2017

Please note, relocation assistance is not available for this position. Only local candidates will be considered.

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Clinical Study Manager, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. North American Commercial is the ‘face’ of AstraZeneca and MedImmune to our many healthcare clients. They represent many of the most well recognized and respected products in the industry, and build strong relationships with healthcare professionals.

Main Duties and Responsibilities

As a Medical Affairs Clinical Study Manager, you work on behalf of US Medical Affairs, accountable for the delivery of US clinical studies according to agreed timelines, budget, and resources. You will ensure compliance with relevant AZ/External Service Provider(s) SOPs, processes, and ICH/GCP guidelines and provides oversight of External Service Provider(s) outsourced deliverables.

In this position, your leadership to the Medical Affairs postmarked clinical studies is key. You will own the internal and external vendor relationship. You will also be independently responsible for the project management of these studies. This will include, but not be limited to, the following:

  • Forecast day to day management of study timelines, budget, materials and development of detailed study level plans in collaboration with External Service Provider(s)
  • Track and manage to agreed study timelines, budget and ensure update of appropriate systems (eg, IMPACT) in collaboration with External Service Provider(s)
  • Monitor the progress of clinical activity and produces regular and ad hoc reports and presentations to US Medical Affairs management as required
  • Oversee and manage budget for assigned studies and negotiates budgets and contracts with External Service Providers(s) and investigative sites


Essential Requirements
  • University degree, preferred in biological science or healthcare-related field
  • Minimum of 5 years of experience in Clinical Operations or other related fields (Medical affairs led studies or Academic led studies)
  • Excellent knowledge of spoken and written English
  • Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development
  • Proven project management delivery and demonstrated ability to manage multiple deliverables
Desirable Requirements
  • Oncology experience
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.