Curis is seeking a Clinical Trial Manager to oversee operational activities supporting our sponsored clinical trials. This person will work closely with internal team members and vendors to ensure that assigned clinical trials are executed in a timely manner and in compliance with all applicable regulations, guidelines, and SOPs. Past experience in all aspects of clinical trial conduct is preferred, with an emphasis on managing Phase I and Phase II oncology studies.
Responsibilities include, but are not limited to:
• Will serve as the clinical lead at Curis, responsible for oversight of all operational aspects of clinical trials, from protocol development to clinical study report generation. This includes vendor and site selection, and ongoing oversight of vendor activities for all outsourced functions-project management, clinical monitoring, data management, etc. This position may serve as the lead for one trial or for several within a clinical program.
• Manage CRO/vendor interactions including sponsor oversight of all delegated responsibilities, scope revisions/contract amendments, budgets and invoices, detailed timelines, and ensuring all expectations have been met.
• Review and/or preparation of study related documents, such as Laboratory Manuals, Pharmacy Manuals, CRF completion guidelines, model informed consent forms, protocol amendments, etc.
• Clinical trial supply ordering and tracking.
• Monitor study progress, review emerging clinical data, and ensuring that data retrieval and clean-up is completed on schedule.
• Maintain regular contact with personnel at clinical investigative sites and/or CROs.
• Conduct co-monitoring visits as needed.
• Ensure that assigned clinical trials are executed in compliance with applicable regulations, guidance and SOPs. Travel to vendor and investigative sites to conduct on-site QC visits at clinical trial vendor facilities and investigative centers.
• Oversee clinical Trial Master File and maintain it for inspection-readiness/due diligence activities.
• Participate in the review and revision of departmental SOPs; provide support to establish and maintain operational infrastructure at the clinical trial and departmental levels.
• Other job related duties as assigned.
Applying candidates must have a Bachelor’s degree in a scientific discipline or the equivalent, with 4+ years of clinical research experience at either a Sponsor or CRO, including at least two years as either a clinical project manager/clinical trial manager or other comparable position. Prior experience directly monitoring and managing cancer clinical trials is strongly preferred. Availability to travel up to 25% or more, depending on project needs, is required.
The ideal candidate possesses knowledge and appreciation of all stages of pharmaceutical drug development, analytical operations, compliance and documentation. He/She must have demonstrated leadership skills with ability to work independently and within high performance teams. This position requires excellent knowledge of monitoring practices, demonstrated knowledge/competence in application of CFRs, GCPs, and ICH guidelines. He/She must possess excellent oral and written communication skills, attention to detail, project management skills, superb organizational and interpersonal skills, and the ability to juggle multiple projects with strict timelines.
Please send CV with job code (CTM500) to:
4 Maguire Road
Lexington, MA 02141
or Fax: 617.503.6501.
No phone calls please.
Curis is an Equal Opportunity Employer.
Curis is a biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers. Our most advanced drug candidate is CUDC-907, an oral, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K) enzymes, which has completed the dose escalation stage of a Phase 1 clinical study. Curis is also engaged in a broad collaboration with Aurigene in the areas of immune-oncology and precision oncology. As part of this collaboration, we expect to exercise options to exclusively license small molecule antagonists of programmed death ligand-1 (PD-L1) and interleukin-1 receptor association kinase-4 (IRAK4) and file IND applications for both molecules.
Our most advanced program, a Hedgehog pathway inhibitor program developed in collaboration with Genentech (Roche), led to the commercialization of Erivedge® (vismodegib), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Genentech/Roche are responsible for the development and worldwide commercialization of Erivedge. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as planned development in other non-oncology indications.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. We offer a competitive salary and benefits package. For more information, visit Curis' website at www.curis.com.