Clinical Program Manager

Clinical Program Manager

On behalf of my client, a global pharmaceutical company, we are working with them on a number of new opportunities for a Clinical Program Manager.

The Clinical Program Manager will be a valued member of the Clinical Operations team in Dublin. He/She will work with the Clinical Trial Manager and study teams to manage studies within a program and across all regions, providing a significant role in oversight and management of programs, leading cross-functional teams, driving performance and ensuring consistent execution of delivery.

Key Responsibilities

• Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Provides Clinical Operations therapeutic area leadership.
• Accountable for successful study completion including clinical trial budgets and timelines.
• Leads cross-functional study management teams and should have good influencing skills with study stakeholders.
• Ensures consistent execution of program requirements across studies in a program.
• Manages study resources and responsible for career development and guidance of direct reports. 
• Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.
• Communicates project status and issues and ensures project team goals are met.
• Writes study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Develops and progresses RFPs and selection and management of CROs/vendors.
• Anticipates moderately complex obstacles and implements solutions to achieve project goals.
• Resolves problems using national and international regulations, guidelines and investigator interaction.
• Contributes to development of abstracts, presentations, and manuscripts.
• Participates in and/or leads departmental or interdepartmental strategic initiatives.
• May design and use all available vehicles for scientific communication within company.
• May design scientific communications.
• Travel is required.

Knowledge, Experience & Skills:

• BSc or BA in a relevant scientific discipline or RN qualification.
• At least seven years relevant clinical trial experience in the pharmaceutical industry.
• Ability to manage and motivate teams and drive performance.
• Ability to develop study team members.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Excels in project management and demonstrates ability to manage studies or programs of  greater complexity from both a process and strategic perspective.
• Demonstrates knowledge of how the clinical trial operations impact the broader strategic goals of the Company.
• Ability to work independently with minimal oversight, identify issues and adapt to changes.
• Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.
• Ability to examine functional issues from a broader organizational perspective.

• Must have functional expertise to initiate, author, or contribute to SOP development, implementation and training.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Excellent interpersonal skills and demonstrated ability to lead is required.
• Excellent verbal, written and presentation skills are required.

For further detail and confidential discussion please contact Tina at +353 1 2784671 or email your CV to tdunne@thornshaw.com   

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com