Senior Clinical Study Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
Stevenage, Hertfordshire
Posting date: 12 Apr 2019
CR.JO.22716_1555074191

ProClinical is pleased to announce that a leading pharmaceutical client is searching for a Senior Manager, Clinical Operations to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

The Senior Manager, Clinical Operations is responsible for the management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing. The immediate need is for the Sr. Manager, Clinical Operations to support two (2) pivotal Phase III global studies for a major submission within the company's Neurology Business Group. This is an exciting opportunity for an individual with demonstrated learning agility to work on a large, high profile global program. This position works with other team members to coordinate preparation of study protocols and final study reports. A detailed understanding of overall strategic direction, interrelationships and business needs is required.

Job Responsibilities:

  • Managing all aspects of study progress from start-up to close-out activities, and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.
  • Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing.
  • Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals).
  • Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
  • Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
  • Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
  • Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution
  • Contributing to individual and team development through training initiatives and team building activities
  • Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome.
  • Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
  • Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
  • Called upon to develop solutions utilizing creativity and ingenuity
  • Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
  • Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
  • Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees

Skills and Requirements:

  • An undergraduate degree.
  • Demonstrable experience in a similar role.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Jack O'Neil at +44 203 846 0646 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-119616263_JO1

#Clinical

close