The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of

Global Pharmaceutical company which focuses in Rare Disease, Oncology and Infectious Disease is hiring a Biosmaple Operations Manager Must have GCP experience and Sponsor experience (Biotech or Pharmaceutical) One year w-2 contract with full benefits offered Or can go permanent Full time Send resume if interested and qualified:Company is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay....

Director, Medical Information for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process....

Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing....

My client is in start-up mode seeks a Director to oversee clinical research and drug safety activities along with clinical research strategy. The ideal candidate will take on the following tasks:Oversee clinical study activities.Recruit, manage and develop a small clinical research and drug safety team.Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, and assist with manuscript preparation.Forecast....

Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....

Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....

Global Pharmaceutical Company with Animal Health Division is expanding the Manager of Health & Safety/Environmental/Security is responsible for managing the work activities of exempt and non-exempt staff whose focus and responsibilities include assuring that Clinton Laboratories operates all of its activities in a manner that meets all state, federal and company HSE and security standards. This individual works closely with the other management leaders of the site as well as the corporate....

Manufacturing Associate (five needs) 1st and 2nd Shifts available 6 month contract, and renewable up to 4 years Company is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines. This position will eventually transition from Cambridge, MA to our new GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials.

The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....