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Clinical Trial Manager

Parsippany, NJ 07054

Posted: 07/12/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 610789 Is job remote?: No Country: United States

Job Description

Duties:    
  • 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 staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Parsippany, NJ

Discover exciting job opportunities in the vibrant area surrounding Parsippany, New Jersey! Known for its picturesque landscapes, proximity to NYC, and diverse range of industries, Parsippany offers a wealth of growth prospects for job seekers. With easy access to iconic landmarks like Mount Tabor, the Stickley Museum at Craftsman Farms, and the Morris Museum, as well as renowned theaters like The Shakespeare Theatre of New Jersey and the Community Theatre, culture enthusiasts will thrive here. Not to mention the delectable array of cuisines available in the area, from classic diners to gourmet dining options. Explore our job listings today and unleash your potential in this charming and dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.