Average salary: $105,000 /yearly
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...manufacturing, and business development. Must have at least 1+ year of client facing/project management experience. Experience with a CMO or CRO environment highly desired.
+ PMP certification or related Project Management professional training is a plus.
+ Ability to...
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...Job Description
Job Description About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global...
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...expertise while leveraging available space.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety...
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...related guidance regarding compliance, personnel and other relevant aspects of trials at multiple research sites, medical institutions, CRO's and Sponsors.
Work location: Kearny Mesa
Essential Duties and Responsibilities:
Administrative Duties (may include, but...
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...Director (AD) to lead our fast-growing bioanalysis platform. The AD will lead a team to achieve long-term research and business goals in a CRO setting. The position will independently design, execute, trouble shoot and deliver the projects with LCMS, including small...
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...spanning chemistry, biology, analytical sciences, pharmacology, DMPK, and toxicology, the candidate will also manage collaborations and CRO resources as needed. This position will report to the VP Chemistry and will have direct reports.
Role and responsibilities:...
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...Assist in review and negotiation of vendor contracts and study site clinical trial agreements.
Setup and manage study vendors (e.g., CRO, IRT, laboratories, central ECG/imaging).
Able to independently review/edit vendor specification documents, as necessary....
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...and preparation for/of Essential Documents (e.g., Patient Informed Consent Forms, 1572s,)
* Identify, manage and supervise clinical CRO and consultant activities.
* Negotiate clinical trial agreements and budgets; manage the budget and vendor site payments.
* Participate...
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...resolution, working closely with ERS colleagues on developing/testing upgrades and bug fixes
Preparation and presentation of CRO key performance indicators (metrics), including compound flow, cycle time, and reaction number analysis
Day-to-day...
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...study sites, as needed.
* Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed.
* Perform study risk management and implement mitigations.
* Identify potential study issues and...
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...applicable regulations and guidelines governing the conduct of clinical trials. The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing,...
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...expectations, and monitoring of the Trial Master File (TMF).
May conduct co-monitoring visits and oversight assessment visits with CRO field CRAs.
Review and follow study Standard Operating Procedures (SOPs), processes, and best practices to ensure trial...
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...managed
Review clinical study protocols to ensure PK, ADA and Biomarker sampling time points are consistent with study design
Manage CRO activities and ensure Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance
Identify, scope out and select...
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...Expert knowledge of toxicologic pathology is beneficial
Expert knowledge of managing clinical Contract Research Organizations (CRO's)
Demonstrated experience in the of preparation of INDs, CTAs, NDAs, and MAAs
Maintains broad knowledge of scientific principles...
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...experiences should not only provide exceptional customer-first interactions but also meet and surpass Conversion Rate Optimization (CRO) goals.
Your role will include uncovering insights, identifying opportunities and requirements, and presenting them to both...
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...sterile cell culture techniques, and rodent handling experience in academic or industry laboratory environment.
* Work experience in CRO or in a commercial setting is preferred.
Knowledge / Skills / Abilities:
* Demonstrated understanding of scientific procedures...
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...drug product development, production, testing and release.
* Experience in a virtual biotech setting working with external CDMO and CRO based resources for preclinical activities, production of drug substance and drug product, testing, and CTM labeling is a plus.
*...
...niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position...
...designing chemical tools, analyzing decoded DEL data, and coordinating DEL hit resynthesis and early follow up with internal and external CRO synthetic resources
Evaluating and developing new DEL technologies either internally or through collaboration with key external...
...strong understanding of clinical trial processes, protocols, and medical terminology
* Prior experience in management and monitoring of CRO and investigative sites, preferred
* Experience with patient recruitment, non-compliance, safety, document management, an...
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