We are looking for a strong leader, an independent worker, and someone who can lead the development and execution of the clinical evidence plan (ensuring global needs are being met, investments are directed the right path, and support growth initiatives). This is both a tactical role (understand business needs, SOP creation, oversee clinical studies) and strategic role (design and oversight, vision for the business, internal expert as it relates to Clinical). This role will guide the future of the business – by doing gap analysis (assisting with new market development through clinical evidence).
In this role you will lead the development and execution of the clinical evidence plan for assigned clinical studies ensuring that global market needs are designed into the plan for clinical trial investments (pre-market and post-market). You’ll work on clinical study planning, trial design, trial execution and trial closeout – not limited to clinical evidence strategy, clinical protocol, data management plan, monitoring plan and clinical report.
- Collaborates and manage cross-functional relationships (internal and external)
- Study site qualification, site selection, site initiation, clinical study monitoring, evaluate clinical results, report generation and clinical evidence publication of trial results in peer-reviewed journals.
- Represents the Global Clinical Affairs department on multi-functional core teams, and at FDA, to ensure program requirements are met and that clinical trials are executed in a compliant, scientifically appropriate manner.
- Be the voice of clinical in marketing collateral review
- Partner with marketing to create and validate compelling messages related to clinical evidence results
Clinical Program Lead
Cincinnati, OH (Relocation Paid)
Competitive Pay, Bonus, Benefits
We have an immediate need for a strong Clinical Affairs/Studies professional, to join a growing division of a multi-billion-dollar global Fortune 500 (medical device/diagnostics manufacturer). Our client has experienced impressive growth over the past 20+ years (10%+ in 2018), and due to recent evolution of the business, have a critical job opening for a Clinical Program Lead.
- Bachelor of Science Required (Advanced Degree preferred not required)
- 5-20+ years’ experience with clinical trial management of medical devices or clinical diagnostics required (class II or class III preferred)
- Clinical research certification (such as CCRA, CCRC) is highly desired.
- Strong experience in evidence planning, clinical strategy, study design/execution and study monitoring
- Ability to work across a dynamic organization and influence internal and external stakeholders
- Ability to resolve compliance or technical issues that may arise during clinical trials.
- Demonstrates strong ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members. Must be able to work independently and be a free thinker.
- Demonstrates strong ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities.
- Ability to travel 20-50% of the time as needed