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Position Summary:  The Sr. Clinical Research Associate will oversee outsourced clinical operations activities including but not limited to site management, site monitoring and site level TMF filing. Additional responsibilities may be assigned (e.g. management of central labs). Job Duties: Oversee outsourced clinical trial monitoring by reviewing monitoring plans, monitoring visit reports, deviation listings, and conducting periodic oversight monitoring visits. Review site training materials including Site initiation visit slides and related materials.  May attend / present at site initiation visits (e.g. present company overview and pipeline slides). Develop or oversee development of study / country master ICFs; facilitating internal reviews as appropriate and applicable. Review subject facing documents (e.g. subject ID cards, subject instruction material) for accuracy against the protocol, IB, consent and other documents as applicable. Oversee site management activities by:Ensuring sites are compliant with GCP, and CROs are appropriate and timely escalation of deviations or non-compliance etc. Serve as primary point of contact for the CRO regarding site level issues. Review site level documents as relevant, e.g. site recruitment plans, site level ICF changes (including facilitation of internal review where appropriate). Ensuring timely collection /submission of updated regulatory documents and that TMF site files are in an inspection ready state. May also conduct or assist with study and country level TMF QC. Track distribution of safety letters to site. Escalate deviations from regulatory timelines to Clinical Project Manager. In coordination with other clinical team members, ensure study data quality by:Ensuring timely data entry and query resolution by sites. Serve as primary escalation point for late data entry / query resolution or lagging source data verification percentage. Support internal clinical data review process (e.g. review data for accurate subject disposition). Action follow-up items as applicable after internal data review meetings (e.g. schedule calls or follow-up with sites where additional discussion may be required). Provide updated site level documentation and applicable updates to regulatory as appropriate (e.g. updated 1572s, communicating site activations/site lists). Contribute to development of vendor oversight plans for outsourced clinical operations activities. ***Remote position in the U.S. 

Position Summary: The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform. Job Duties and Responsibilities:  Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform. Select and onboard/implement an archival TMF platform. Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible. Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings. Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections. Stay current with regulatory requirements and industry best practices related to records management and TMF.

The Executive Director, Clinical Development will be responsible for providing clinical and scientific input into the development strategy for the clinical portfolio. In addition, the Dir., Clinical Development will provide medical oversight for ongoing clinical trials, including study document development (protocols, IBs etc.), overseeing outsourced medical monitoring, participating in internal clinical data reviews and assessments for safety reports. Job Duties: 1. Develop and support implementation of the clinical development strategy for the entire portfolio. In conjunction with program management, author clinical development plans. 2. Support interactions with health authorities by providing clinical and scientific expertise and input into drafting of various submissions  (INDs, annual reports, NDAs, inquiry responses etc). Attend meetings with health authorities as needed. 3. Provide medical oversight of ongoing clinical trials: a. Review, analyze and interpret safety information for clinical trials and provide recommendations based on emerging safety data where appropriate. b. Compile, analyze and present safety data analysis at (internal and/or external) safety review committee meetings. c. Maintain oversight of outsourced medical monitoring activities for quality and study plan and SOP compliance. d. Serve as medical resource for internal and external study teams to address medical / protocol related questions. e. Regularly attend study team meetings. f. Work with clinical team to ensure data collected are of high quality, including contributing to development of CRFs, edit checks and data review plans and regularly performs medical data review (including coding reviews). 4. May complete medical review including causality assessments for individual case safety reports and other safety/medical related regulatory documents. 5. Lead development of scientific publications, clinical trial design and protocols, investigator brochures and other study and/or asset level documents. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities. 6. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.

General Summary: The Director of Clinical Supply will be responsible for overseeing the planning, coordination, and management of clinical trial materials and supplies. This role requires a strategic thinker with strong leadership skills, who can ensure the efficient and timely delivery of clinical supplies to support our clinical development programs. Job Duties and Responsibilities:  Strategic Planning and Management: Develop and implement clinical supply strategies to support clinical trial timelines and objectives. Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs and CMC, to ensure alignment on clinical supply needs and priorities. Oversee the demand forecasting and supply planning, for clinical trial drugs. Operationalization and Oversight: Manage the procurement, packaging, labeling, and distribution of clinical trial comparator products. Ensure compliance with all regulatory requirements and Good Manufacturing Practices (GMP) standards. Oversee the selection and management of third-party vendors and contract manufacturing organizations (CMOs) involved in the clinical supply chain. Create applicable trial documentation (e.g. pharmacy manual, labels) with input from relevant functions. Set-up and oversight of Interactive Response Technology (IRT) platforms used on clinical trials. Ensure timely and accurate financial reporting and forecasting related to clinical supplies. Quality and Compliance: Implement and maintain robust quality systems and processes to ensure the integrity and quality of clinical trial materials. Ensure compliance with all applicable regulatory guidelines, including FDA, EMA, and ICH guidelines. Lead the investigation and resolution of any quality issues related to clinical supplies.

Position Summary: This role will be responsible for oversight of outsourced data management activities and be charged with developing data management oversight and data cleaning processes and a CRF library. Major Duties and Responsibilities:  Oversee outsourced data management activities by ensuring the design, development and maintenance of clinical databases meets regulatory requirements and industry standards and developing and monitoring key performance indicators (KPIs) for data management service providers. Ensure timely and appropriate reconciliation of external data sources against clinical databases on assigned studies. Collaborate with cross-functional teams including Clinical Operations, Biostatistics and Clinical Development to ensure high quality and on time delivery of study level data. Collaborate with internal stake holders to develop an internal data review process. Manage internal data review process and issuing / resolution of queries. Develop global CRF library for re-use on future studies to improve study database build timelines.