Planet Pharma

Clinical Trial Manager

Planet Pharma Parsippany, NJ
Planet Pharma

Clinical Trial Manager

Planet Pharma Parsippany, NJ
1 month ago 68 applicants

See who Planet Pharma has hired for this role

Pay found in job post

Retrieved from the description.

Base pay range

$60.00/hr - $84.00/hr
Duties

Job Description

  • Executes clinical studies to establish the safety, efficacy and commercial viability of company products.
  • Participates in the formulation of overall clinical development strategy.
  • Experience in conduct of pediatric and adult hospital- or clinic-based clinical research trials.
  • Manage Phase 1-4 clinical research and operations including strategic direction, clinical trial protocol design and initiation of clinical trials to optimize tactical and clinical value through US and Global Clinical Trial Site Selection and data portability.
  • Actively participates as one of the lead research team members interacting with and providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
  • Manages study timelines, and budgets to include negotiating contracts with study vendors, CROs and clinical trial sites.
  • Works with Clinical Strategy and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.
  • Leads and coordinates a multidisciplinary clinical study team.
  • Communicates and interacts frequently and effectively with in-house personnel, clinical sites and outside contractors/CROs.
  • Participates in investigator meetings.
  • Participate in the development, revision, review and implementation of company SOPs for Phase 1-4 clinical trials and trial related activities.
  • Ensure company compliance with all applicable regulatory standards related to US and global clinical trials and interactions with physicians including but not limited to Sunshine Act.
  • Develop and maintain professional relationships with academic and community-based physicians, clinicians and principal investigators to assure good clinical input to our product development process, marketing and sales teams.
  • Interface with departments within and outside of company including Clinical Strategy, Regulatory Affairs, Compliance, Pharmacovigilance, Commercial, Marketing, Medical Affairs and Sales Teams.
  • Provide assistance in preparing updates and status reports for Executive/Senior Management on a regular basis to include performance against the plan.

Skills

  • Demonstrated detailed knowledge of medical/surgical procedures, and acute and chronic pain practices (pain management standards and guidelines preferable but not essential).
  • Demonstrated solid working knowledge of cGCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations including NDA, 505(b)(1), 505(b)(2), 510 (k) regulatory pathways, pediatric research guidelines, European, APAC, LATAM and global Regulatory Authority Submissions etc.
  • Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence.
  • Demonstrated commitment to working within Regulatory and Compliance constructs.
  • Strong MS Office Skills
  • Excellent analytical and organization skills; able to set priorities and meet deadlines.
  • Ability to work effectively on a team in an entrepreneurial environment.
  • Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems.
  • Extraordinary research skills, vast experience conducting hospital- and clinic-based research trials and expertise in searching medical literature and databases for clinical, medical and technical information.
  • Proven ability to forge cross-functional working relationships with internal teams. Clinical Trial Sites/PI’s, external contractors, vendors, and customers.
  • Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the clinical trial and resolve the issues in a timely fashion.
  • Ability to travel up to 20% with short notice when necessary.
  • Ability to comply with all medically required hospital/clinical site immunization requirements.
  • Valid driver’s license in the state in which you reside.

Education

  • Advanced degree in a health, biological sciences or research related field from accredited college or university, or equivalent experience
  • Minimum 8 years of experience in pharmaceutical / medical device industry with at least 6 years of hands-on managerial experience running clinical trials and managing teams.
  • Minimum 6 years of experience working in the CRO matrix environment managing global development program as a Lead Clinical Research Associate (CRA)/Clinical Trial Lead (CTL) or Clinical Program Lead (CPL) preferred.

Certifications & Licenses

  • Clinical Research Associate
  • pain management

Pay Rate Range: $60-84/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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