Overview
SUMMARY:
We are currently looking for a skilled professional to join a well-known client’s team as Senior Clinical Study Manager. The responsibility will include to ensure on-time delivery of clinical studies through day to day project management. His/her work will not only have a direct impact on the output of the organization but also on the clinical industry at large, making this an amazing career opportunity.
Responsibilities:
- Create and drive study level timeline
- Develop overall feasibility concept and enrollment plan with input from team leads
- Build and manage study budget
- Provide input on operational aspects of the protocol
- Ensure regulatory compliance and GCP compliance
- Oversee TMF with periodic audits
- Contribute to vendor selection and management including issue escalation
- Plan, facilitate, and lead internal meetings as well as act as the lead for vendor meetings
- Ensure monitoring plan is developed and consistently executed
- Lend to the development of proactive strategy and corrective action plan to address study issues
- Assign and document study specific roles and responsibilities to internal and external team members
- Facilitate and coordinate communications with external provider
- Report key study performance information
- Facilitate study close out activities through completion of Clinical Study Report
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Ensure standard processes, tools, and procedures are used consistently for study execution
EXPERIENCE:
- Must have experience in handling Oncology Trials, especially Phase I – II studies.
- 4-5 years as Study Manager relevant clinical research (or related) experience within the pharmaceutical industry required
- 2 years as CRA
- Solid understanding of the drug development process and each step within the clinical trial process
- Comprehensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory information
- Demonstrated experience in overseeing global clinical trials (pharmaceutical or research institute)
- Budget forecasting and management experience
- Detailed knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process required
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experience working within a Matrix Environment
- Experience in scientific/medical research desired
- Sponsor and CRO experience preferred
EDUCATION:
- Minimum of Bachelor’s Degree required, degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
To be a best-fit your strengths must include:
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
