Early Clinical Development Program Manager
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Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Develops and maintains liaison with clinical investigators, medical educators, clinical research organizations (CRO), affiliated hospitals, state and/or government hospitals, and research institutions to initiate and expedite clinical studies. Determines and monitors time schedules, prepares study documents, and issues status reports. May assist with design, development, and monitoring of clinical evaluation projects. (These roles do not require a specialized medical degree.)
Main Responsibilities and Accountabilities
- Clinical project management of an ED clinical program/study.
- Create and drive study level timeline.
- Develop overall feasibility concept and enrolment plan with appropriate input from internal stakeholders.
- Develop and manage study budget.
- Provide input on operational aspects of the protocol.
- Ensure regulatory compliance and GCP compliance.
- Responsible for oversight of Trial Master File TMF with periodic audits.
- Responsible for/contribute to vendor selection and ongoing management and oversight of all outsourced activities.
- Develop and manage Study Management Plan and all associated documents (i.e. vendor oversight plan).
- Collaborate with vendors and internal stakeholders to ensure that data is available for review by the Safety Review Committee in a timely manner.
- Collaborate with Clinical Supplies & Logistics team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies.
- Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings.
- Ensure monitoring plan is developed and consistently executed in collaboration with appropriate stakeholders.
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and internal stakeholders.
- Ensure Clinical Operations team and external partner receive study specific training.
- Report key study performance information.
- Facilitate study close out activities through completion of Clinical Study Report.
Qualifications and Experience
- Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience.
- A minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in overseeing global clinical trials (pharmaceutical or research institute).
- Budget forecasting and management.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process; maintain current medical/scientific/regulatory knowledge.
- Demonstrated ability to lead teams and work in a fast-paced team environment. Experienced in working within cross-functional team in a Matrix Environment.
- Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Negotiation and influential skills advantageous.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
- Excellent written and oral communication skills.