Manager of Clinical Research Trials
2 weeks ago
Position: Clinical Trial Manager (REMOTE)
Contract Duration: 12 Months
Compensation: Starting at $65/hr on W2 (Negotiable)
Key Responsibilities:
- As the Clinical Trial Manager (CTM), you will be responsible for overseeing the operational aspects of the local segment of a clinical trial.
- Your oversight will ensure that recruitment targets, timelines, budgetary constraints, and quality standards—both internal and external—are met.
- You will lead the local trial team to maintain the integrity of trial execution, prioritize patient safety, and ensure that the local and regional components of the trial are executed in compliance with regulatory standards.
- This role requires the coordination of the local trial team and collaboration with other departments throughout the planning, execution, and conclusion of the trial.
- You will operate within a complex GCP and regulatory framework, engaging with multidisciplinary, international teams and various stakeholders, including suppliers and investigational sites. You will represent SPECTRAFORCE in internal and external meetings, including discussions with investigational sites and regulatory bodies.
- In this role, you will manage multiple assignments simultaneously, balancing competing priorities while ensuring project deliverables are met. You will also contribute to the design and implementation of innovative methodologies as a member of working groups.
Trial Management Responsibilities:
In collaboration with the Site Monitoring Lead and Clinical Research Associates (CRAs), you will serve as the primary contact for CRAs, investigators, and site personnel.
Essential Skills:
- Exceptional communication abilities within complex cross-functional environments. You will articulate and align business strategies consistently, ensuring coherence between actions and words. High-level receptive communication skills and cultural awareness are crucial.
- Proficient project management, stakeholder engagement, and team leadership skills. A solid understanding of the scientific and technical aspects of the clinical development process and related regulatory requirements is essential.
- Technical Expertise: You will demonstrate comprehensive knowledge of all facets of clinical trial operations and execution. Familiarity with a relevant Therapeutic Area is advantageous. The complexity of trials in this project management role encompasses protocols, trial subjects, sites, countries, and suppliers. The ability to manage multiple studies across various Therapeutic Areas is necessary.
- Leadership and Influence: Your skills in navigating complex situations, resolving conflicts, and influencing across horizontal and vertical structures will be key.
- Strategic Mindset: You will embrace cross-functional initiatives, applying innovative insights while identifying risks and planning for mitigation.
- Coordination and Oversight: Your ability to prioritize tasks, manage activity pace, and utilize resources efficiently will be critical.
- Willingness to travel domestically (10-20% of the time) is required.
Qualifications:
- A Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or
- A Master's degree or PharmD with at least 4 years of experience in clinical research, preferably within the pharmaceutical sector; or
- A PhD or MD with a minimum of 2 years of experience in clinical research, preferably within the pharmaceutical sector.
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