Global Clinical Program Manager
|Contact Name:||Larry O’Leary|
Our client, a Biopharma company with strong development pipeline and multiple blockbuster products, now seeks an experienced Clinical Program Manager to work within their Clinical Operations team based in Dublin. This hire will provide oversight for the successful management of all aspects for a number of global clinical trials within designated program budgets and timelines.
The successful candidate 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.
The ideal candidate will be an experienced Clinical Program Management in successfully providing oversight of clinical trials; who has excellent teamwork, communication, decision-making and organizational skills and ability to work effectively in a dynamic environment.
Responsibilities of Global Clinical Program Manager:
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.
Requirements for Global Clinical Program Manager:
Bachelor’s degree and minimum of 10 years relevant Clinical Operations experience, with progression to Clinical Program Manager level and relevant experience.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
Excellent project management and proven ability to manage studies or programs of greater complexity from both a process and strategic perspective.
Proven experience in managing and motivating teams and driving performance; and developing study team members.
Proven ability to interact cross-functionally at senior levels within the Company.
Proven ability to successfully develop, implement, manage and complete clinical trials.
Functional expertise to initiate, author, or contribute to SOP development, implementation and training.
Strong communication, decision-making, organizational skills and influence skills and ability to create a clear sense of direction is necessary.
Technical proficiency in trial management systems and MS applications including; Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
Effective communication skills via verbal, written and presentation abilities
Ability to influence and negotiate.
For further details please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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