Open Positions
- CLIN OPS SOLUTIONS
Remote USA
At Clin Ops Solutions, we partner with biotechnology and pharmaceutical organizations to connect clinical research professionals with exciting career opportunities.
Not all of our opportunities are posted on our website. Many of our searches are confidential or filled directly through our talent network.
If you’re ready for your next opportunity, we’d love to hear from you. Submit your resume, and our recruitment team will contact you when a position aligns with your experience and career goals.
- CLIN OPS SOLUTIONS
Employment Type: full time
Full time (permanent) Clinical trial manager for a small Cambridge-based biotech. Primary responsibility upon joining company will be to support start up and oversight of a new large global clinical study.
- At least 5 years industry experience with at least 1 year as lead clinical trial manager from within biotech/sponsor side.
- Ability to work from the office at least 3 days/week.
- CLIN OPS SOLUTIONS
Employment Type: Permanent
- Leads development and review of statistical deliverables including protocols (statistical sections), SAPs, TLFs, and CSR statistical content
- Ensures compliance with regulatory requirements, including ICH E9, GCP, and company SOPs
- Oversees biostatistics vendors and CROs, ensuring quality, consistency, and timeliness of deliverables
- CLIN OPS SOLUTIONS
Type: Full-time
- CLIN OPS SOLUTIONS
Employment Type: Contract
- Provide oversight of outsourced pharmacovigilance operations, including case processing, regulatory reporting, literature surveillance, and safety database activities.
- Serve as the primary operational contact and relationship manager for the CRO, ensuring adherence to service level agreements (SLAs), key performance indicators (KPIs), and contractual obligations.
- Monitor operational performance, quality, and regulatory compliance, and drive issue resolution, risk mitigation, and corrective and preventive actions (CAPAs) as needed.
- Lead routine governance meetings, review operational metrics, and communicate vendor performance and risks to internal stakeholders.
- Ensure inspection and audit readiness by maintaining appropriate oversight documentation and supporting internal and regulatory inspections.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Safety, and other stakeholders to support successful pharmacovigilance operations.
- Identify and implement process improvements to enhance operational efficiency, compliance, and vendor performance.
- CLIN OPS SOLUTIONS
Remote USA
- Participates in the internal cross-functional study team(s)
- Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
- Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report
- Assists in the preparation and review of the protocol, informed consent form, case report forms and associated completion guidelines, and other study documents
- Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals
- Participates in study feasibility activities
- Oversee study activities such as: selection of investigators, study start-up activities including site initiation and study monitoring activities
- Verified Company
Treva Agency
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
- Full Time
- $20k - $25k