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- Newton, MA

Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications with various vendors Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks),....


Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications with various vendors Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks),....


Job Description Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilitiesWorks to ensure adherence to a standardized approach to project managementManages clinical trials projects through leadership of and delegation to a cross-functional study execution team, Ensures successful clinical trial planning, execution and delivery – within specified quality, time....


KEY ACCOUNTABILITIESImplements, conducts or monitors on-site clinical trials.Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas.Leads own team of professional staff to....


SPECIFIC JOB DESCRIPTIONKEY ACCOUNTABILITIESImplements, conducts or monitors on-site clinical trials.Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas.Leads own team of....


Position Summary The Sr. Statistical Programmer demonstrates quality in all actions; Works in partnership with Biostatistics, Data Management and Clinical Operations to conduct statistical programming . Develops SOPs for internal programming practices, oversees vendor activity associated with statistical programming services, contributes to clinical data reports for all IDE updates and submissions and interfaces with other departments within (Marketing, Healthcare Economics, Clinical....

- Cambridge, MA

Responsible for Pharmacovigilance Operations activities for all safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with....


The Principal Clinical Data Manager demonstrates quality in all actions; Responsible for managing and/or executing the design, documentation, testing, and implementation of data collection systems and processes through the lifecycle of a clinical trial. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts....


As Head of Quality, this position will be responsible for driving a comprehensive quality strategy and quality system for the company. Working with the company senior leadership and line function heads to define an overarching quality strategy, systems and culture that is applicable to the activities that occur within the company. That will allow the basis to structure/build the group necessary to execute on the agreed upon strategy.Activities include management and GMP oversight of product,....

- Newton, MA

Primary Duties Manages the planning, implementation, and execution of a clinical research study(ies). Manages clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. May author, review and approve various study related documents and plans. Leads cross-functional teams and is responsible for the oversight and management of study timelines. ResponsibilitiesLeads the study team to design, develop and deliver the clinical study to agreed upon timelines.May assist in....


We are looking for Clinical Study Leads to help us initiate and manage Ph I-II, global and/or domestic oncology trial(s). The position will be responsible for planning, implementing and managing trials, working as part of a dynamic clinical development team. If you enjoy a start up environment and are looking to contribute to a very talented clinical team, we are the company for you. For the right person, we are flexible with title for the position and will consider Senior Manager through....

- Cambridge, MA

Job Description Reporting to the Director, Clinical Operations, the successful candidate will manage clinical project activities ensuring the timely completion of deliverables through development and management of the project timeline and budget. Must be comfortable managing a clinical project through the use of vendors, and be able to manage interactions with and between monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. Externally manage CROs,....


Job Summary Head the Quality function at Akebia. Responsible for the development, implementation, and administration of the Quality Management System (QMS) including activities, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. Activities include management and oversight of product development, testing, stability, validation data, documentation, and records relating....


Description: Directs all aspects of the Clinical Operations Department including oversight of operations and development of procedure and standards for clinical trials monitoring and trial management. Responsible for planning and scheduling workload and staff levels, and ensuring adequate levels of training are carried out to meet performance and quality standards in handling of multi-site and multi-project work. Responsible for strategic planning, implementation and management of the Clinical


Roles and ResponsibilitiesFormulate, establish and maintain policies and procedures and accompanying system related to cGMP, GCP and GLP compliance with global regulatory requirements.Establish and maintain an overall Quality System to support Phase 3 and commercial cGMP activities.Manage document control and training systems.Establish and maintain systems for vendor qualifications and audits for GXP activities.Lead preparations for and manage preapproval and routine regulatory agency....

- Cambridge, MA

Job DescriptionWe are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, AKB-6548, to be a best in class HIF-PH inhibitor for the safe treatment of anemia secondary to CKD. AKB-6548 has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b.....

- Cambridge, MA

OBJECTIVES: Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP). Leadership of the cross functional Study Execution Team (SET), including Takeda functions, Strategic Partners and other vendors, to ensure study objectives are met, on time and within budget.....

- Cambridge, MA

Required SkillsPropose and design well-informed regulatory strategies for the US and EURepresent Regulatory Affairs on project subteams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g., protocol reviews, report reviews, development plans)Assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS)Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs,....

- Cambridge, MA

Roles and ResponsibilitiesAs a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.Manage and ensure compliance with all reporting requirements, including annual and periodic reports.Organize and manage regulatory meetings with health authorities.Review....

- Cambridge, MA

Job DescriptionWe are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, AKB-6548, to be a best in class HIF-PH inhibitor for the safe treatment of anemia secondary to CKD. AKB-6548 has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b.....

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