Search for Jobs

47 Results
Clarity Pharmaceuticals
Massachusetts, United States (remote)
20 hours ago
ENANTA Pharmaceuticals, Inc.
Watertown, Massachusetts, United States (hybrid)
2 days ago
University of Utah
Salt Lake City, UT, United States (on-site)
7 days ago
Cancer Research And Biostatistics (CRAB)
seattle, WA, United States (hybrid)
17 days ago
Cancer Research And Biostatistics
SEATTLE, WA, United States (hybrid)
22 days ago
Hospital for Special Surgery
New York, NY, United States (on-site)
30+ days ago
Salud Family Health
Brighton, CO, United States (hybrid)
30+ days ago
Good Samaritan Medical Center
US
Jobs from the Web
Twill
New York, NY, US
Jobs from the Web
Johnson & Johnson
West Chester, PA, US
Jobs from the Web
Implant Direct
Brea, CA, US
Jobs from the Web
Cardinal Health
IL, US
Jobs from the Web
Bio-Rad Laboratories, Inc.
CA, US
Jobs from the Web
RELX
PA, US
Jobs from the Web
Cardinal Health
OH, US
Jobs from the Web
Ortho Clinical Diagnostics
US
Jobs from the Web
Compassus
Brentwood, TN, US
Jobs from the Web
Mount Sinai
New York, NY, US
Jobs from the Web
Thermo Fisher Scientific
MI, US
Jobs from the Web
Cardinal Health
MA, US
Jobs from the Web
Azenta
Remote, US
Jobs from the Web
Johnson & Johnson
Raritan, NJ, US
Jobs from the Web
Accel Clinical Services
Lake Mary, FL, US
Jobs from the Web
Indica Labs
Albuquerque, NM, US
Jobs from the Web
Medela LLC
McHenry, IL, US
Jobs from the Web
1 - 25 Results of 47
Clarity Pharmaceuticals
Massachusetts, United States (remote)
20 hours ago

Description

About Clarity
Clarity Pharmaceuticals is a leading radiopharmaceutical company developing Targeted Copper Theranostics (TCT’s) for the treatment of serious disease. TCT’s leverage the perfect pairing of Cu-64 for diagnosis and Cu-67 for therapy. We are currently expanding our team to help facilitate the expansion of our clinical trials. Clarity Pharmaceuticals is a small multi-disciplinary team, where all team members support each other in a variety of activities. We are looking for a team member who is motivated to take on new challenges and excited to help grow the company.

About the position
The clinical operations project manager is accountable for planning, executing and reporting on clinical studies, taking responsibility for overseeing performance and quality standards on assigned trials to ensure delivery on time, on budget and in compliance with Clarity processes, KPIs, quality standards as well as local regulatory requirements. This position is key to good communication and professional relationships with internal and external stakeholders. Reports to Associate Director, Clinical Operations.

Duties and Responsibilities

• Responsible for end to end management of trials as assigned from planning through to study close-out.
• Manage 3rd party vendors including CROs, central imaging core labs, and other as required.
• Work closely with relevant team members to develop/review essential trial documentation, including but not limited to clinical study protocol, monitoring plan, protocol deviation plan, communication plan to ensure compliance with Clarity SOPs
• Facilitate preparation and collection of study related documents; resolve problems as required
• Drive the conduct of the trial, track and oversee progress and status including but not limited to study start up, monitoring frequency, prompt site issue resolution, TMF maintenance, drug supply management.
• Present study status reports of operational execution activities to senior management
• Appropriately escalates issues in a timely manner and ensures resolution.
• Lead and chair study team meetings.
• Track trial budget with management team ensuring study budgets are adhered to.
• Track Vendors and/or internal Study Management Team performance against deliverables, contract and timelines.
• Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues.
• Manage data at the third party/site level (as applicable); resolve technical and content issues to achieve aggressive database lock targets. Ensure regular SAE database reconciliation is performed with clinical database.

• Ensure that all trial close–out activities are performed, in close cooperation with field monitors and 3rd party vendors.
• Oversee vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate as required
• Mentor / coach CRAs as needed to ensure trial success. This may involve co-monitoring visits with site CRAs
• May act as a study CRA to meet company needs.
• Support the development and maintenance clinical SOPs & trial process’ as required.
• May support other functions if required to achieve overall company objectives.
• Build a positive culture within clinical operations and cross-functionally.



Requirements

Education and Experience
• Degree in scientific or healthcare discipline.
• Ideally 5-7 years pharmaceutical industry experience, including a minimum of 4+ years of independent trial management preferred
• Experience in a monitor role or a role overseeing clinical trials
• Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes
• Oncology and/or radiopharmaceutical experience preferred
• Strong Project Management skills
• Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
• Ability to convey complex ideas in a simple manner to management and external stakeholders
• Demonstrated ability to work independently.
• Team oriented mindset and demonstrates ability to work with cross functional teams.
• Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment
• The ability to work off hours as needed to ensure our clinical trials are delivered efficiently and on time and problem solve independently as needed
• This is a remote position, with limited expectations around travel (<20%)

Job Information

  • Job ID: 67025379
  • Workplace Type: Remote
  • Location:
    Massachusetts, United States
  • Company Name For Job: Clarity Pharmaceuticals
  • Position Title: Clinical Operations Project Manager
  • Job Function: Clinical,
    Oncology,
    Project Management
  • Job Type: Full-Time
Biotechnology

At Clarity, our mission is to develop next-generation radiopharmaceutical products that improve treatment outcomes for children and adults with cancer. Clarity is a clinical stage radiopharmaceutical company developing next-generation theranostic (therapy and imaging) products, based on our platform SAR Technology. The SAR Technology is ideally suited for use with copper isotopes, enabling superior imaging and therapeutic characteristics of radiopharmaceutical products and addressing the current manufacturing and logistic...

View Full Profile

Jobs You May Like
Filters
Workplace Type
Job Function
Industry
State