Planet Pharma

Clinical Trial Manager

Planet Pharma Ridgefield, CT

Pay found in job post

Retrieved from the description.

Base pay range

$50.00/hr - $70.00/hr
Duties

Job Description

  • As Clinical Trial Manager (CTM), accountable for the operational management of the local component of a clinical trial.
  • Level of oversight assures achievement of trial recruitment commitment, timelines, budget, and internal/external quality standards.
  • Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted, and reported in line with regulatory requirements.
  • Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct, and closeout of trial.
  • Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.
  • Represents the company for the function at internal and external meetings, e.g., with investigational sites or regulatory agencies/inspectors.
  • Failure can have impact on project deliverables (e.g., timelines, costs, integrity of trial data), the reputation of company with stakeholders and regulatory agencies.
  • More than one assignment in parallel requires balancing conflicting priorities.
  • Is involved in the design and implementation of new innovative methods as a working group member.
  • Leads the local trial team as the US Clinical Trial Manager (CTM).
  • Trial Preparation, Conduct, and Closeout:
  • In collaboration with Site Monitoring Lead and CRAs, ensure trial contact for CRAs, investigators, and site staff.

Skills

  • Strong communication skills in complex cross-functional matrix structures.
  • Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
  • Highly developed receptive communication skills and cultural sensitivity.
  • Solid project management, networking/stakeholder management, and team leadership capability.
  • Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements.
  • Technical Expertise: Demonstrates knowledge across all aspects of clinical trial operations and execution.
  • Knowledge in a relevant Therapeutic Area is an asset.
  • Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers.
  • Ability to work across several studies and in different Therapeutic Areas.
  • Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.
  • Strategic Mindset: Embraces cross-functional initiatives, applying innovative learnings.
  • Identifies risks and plans mitigation.
  • Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.
  • Ability and willingness to travel domestically (10-20% of time).

Education

  • Bachelor's degree plus a minimum of 6 years of experience in clinical research, preferably in the pharmaceutical industry; or
  • Master's degree or PharmD plus a minimum of 4 years of experience in clinical research, preferably in the pharmaceutical industry; or
  • PhD or MD plus a minimum of 2 years of experience in clinical research, preferably in the pharmaceutical industry.

Pay Rate Range: $50-70/hr. Salary will be commensurate with experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
  • Seniority level

    Not Applicable
  • Employment type

    Full-time
  • Job function

    Research, Analyst, and Information Technology
  • Industries

    Staffing and Recruiting

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