Sr Clinical Project Manager

Alpha Clinical Development; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Study Manager to lead oncology trials. This role is pivotal in driving the success of clinical studies through effective project management, ensuring regulatory compliance, and overseeing budgets. You will collaborate with cross-functional teams and external vendors, making impactful decisions that shape the future of clinical research. If you thrive in a fast-paced environment and are passionate about advancing healthcare, this opportunity offers a platform to showcase your expertise and make a difference in the clinical landscape.

Qualifications

• 4-5 years as Study Manager in clinical research within the pharmaceutical industry.
• Solid understanding of drug development and clinical trial processes.

Responsibilities

• Manage clinical study timelines and budgets while ensuring compliance.
• Oversee vendor management and facilitate internal and external meetings.
• Report key study performance and facilitate study close-out activities.

Skills

Oncology Trials Management

Clinical Research

Regulatory Compliance

Budget Management

Team Leadership

Problem Solving

Time Management

Education

Bachelor’s Degree in Life Science

Degree in Nursing

Degree in Pharmacy

Job description

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 ensuring 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:

1. Create and drive study level timeline
2. Develop overall feasibility concept and enrollment plan with input from team leads
3. Build and manage study budget
4. Provide input on operational aspects of the protocol
5. Ensure regulatory compliance and GCP compliance
6. Oversee TMF with periodic audits
7. Contribute to vendor selection and management including issue escalation
8. Plan, facilitate, and lead internal meetings as well as act as the lead for vendor meetings
9. Ensure monitoring plan is developed and consistently executed
10. Lend to the development of proactive strategy and corrective action plan to address study issues
11. Assign and document study specific roles and responsibilities to internal and external team members
12. Facilitate and coordinate communications with external provider
13. Report key study performance information
14. Facilitate study close out activities through completion of Clinical Study Report
15. Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
16. Ensure standard processes, tools, and procedures are used consistently for study execution

EXPERIENCE:

1. Must have experience in handling Oncology Trials, especially Phase I – II studies.
2. 4-5 years as Study Manager relevant clinical research (or related) experience within the pharmaceutical industry required
3. 2 years as CRA
4. Solid understanding of the drug development process and each step within the clinical trial process
5. Comprehensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory information
6. Demonstrated experience in overseeing global clinical trials (pharmaceutical or research institute)
7. Budget forecasting and management experience
8. Detailed knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process required
9. Demonstrated ability to lead teams and work in a fast-paced team environment.
10. Experience working within a Matrix Environment
11. Experience in scientific/medical research desired
12. Sponsor and CRO experience preferred

EDUCATION:

1. 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:

1. Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
2. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
3. 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.
4. 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.
5. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
6. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.