The Quality Management Process Analyst will have the following duties: Revamp the current state procedures across different functions that support biospecimens Develop an environment of inspection readiness within the biospecimens group Help with the end to end process analytics Develop quality and compliance metrics Define requirements for and aid in vendor selection for the new QMS Aid...

We are looking for a Global Regulatory Affairs Project Manager with a focus on innovation. Duties: Drive Global Regulatory Affairs innovation efforts Actively engage and collaborate with the Innovation Lead and other GRA leaders to achieve the goals set out in the innovation agenda Employ solutions to enhance processes, technology and activities Lead cross-organizational innovation...

Drive proper project chartering and setup. Facilitate the definition of the project scope, milestones, tasks, deliverables and resource requirements. Identify necessary management structures for projects, and secure the management involvement required. Establish a communication strategy in partnership with business and IT sponsors and effectively communicate project related information to...

Need someone to lead a project to develop structure and processes for a new resource management capability. Person needs to be solid project manager with very good knowledge of resource management, especially organizational structure and key processes. Also needs good working knowledge of clinical ops and how to develop algorithms for clinical ops roles. Job Responsibilities:  Lead project...

The Global IIS Manager will have a good scientific background and 5+ years clinical trials experience. Experience should be specifically with IIS.  Job Duties Interact with Med Sci Liaisons, run meetings, draft meeting minutes, manage timelines and logistics Monitor IIS mailbox and receives all proposals (concepts or full protocols) Update IIS tracker pre and post IISC meetings ...

Job Description We are seeking a Publications Manager who will develop, deliver, and drive the execution of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials. Job Responsibilities: • Support standardization across the geographies. • Work with agency partners to ensure...

Job Description We are seeking a CMC Project Manager to help drive the overall success of development programs within Manufacturing & Technical Operations. S/he will work collaboratively with the Technical Leads and their project teams to plan, track and report the diverse activities managed by Manufacturing & Technical Operations. This includes, but is not limited to, process development,...

Overview The Drug Development Program Manager will be responsible for driving critical execution objectives for the clients’ early and lead late-stage programs as well as other R&D programs in partnership with the Program Team Leads. The position requires excellent communication and leadership skills, in addition to a strong technical understanding of the interdisciplinary nature of early to...

A Principal Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete...

Job Description: The Development Project Manager is responsible for the direction, coordination, implementation, control, and completion of projects while remaining aligned with company strategy, commitments, and goals. This person will oversee initiating, planning and executing projects. The primary focus of the PM will be to manage critical projects. This includes partnering with the project...

Principal Responsibilities: Help define the project with the project sponsor and work stream leads Develop and implement best project team structure to ensure the project is delivered on time with the highest quality Develop and update the project timeline Facilitate meetings and take minutes Follow up on action items Collaborate with the team members to ensure timelines will be met ...

Job Description The Drug DevelopmentProject Manager acts as a central contact for information on a particular program and manages activities to develop programs. Ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. Works with management staff and teams to create the development strategy, establish objectives,...

Position Requirements: Proven ability to lead effectively in a matrix environment Management or Sr. Level experience in biotech or pharma industry with strong preference for candidates with at least 2-3 years of experience in a similar role who have the ability to operate with a high level of independence and minimal oversight Demonstrated drug development expertise that includes...

The Project Coordinator (PC) is a role to offload the more administrative/ data maintenance duties from our Project Managers. The PC should have the skills to take meeting minutes, edit MS Project timelines, edit and organize electronic files, understand and edit budget spreadsheets, and generally interact with PMs and team members to plan and organize the work. Required Capabilities: Skill...

Duties: The Associate Director, Clinical Project Lead is responsible for the operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspectio...

The Project Manager must generally be steeped in the business of drug development with the ability to take on work from our team and advance agreed deliverables with a high degree of independence. They must be comfortable working with teams and articulate both verbally and in written communications. MS Project is the key medium by which we develop timelines and any candidate we consider will be...

Duties: Participates in study teams/representative for PV operations Authors Safety Documents including Study Safety Reporting Plans Work autonomously in the clinical trial space Responsible for SAE Reconciliation, SUSAR review Experienced with Argus Database Global regulatory reporting/compliance Understanding of MedDRA coding conventions Ensures follow-up & query process ...

Duties for the External Innovation PM include: Expertise in developing traditional and innovative strategies to pursue collaborations with external partners to acquire, co-develop and/or invest in new clinical-stage assets that enhance the breadth and quality of our organization’s exposure to new innovation and results in tighter integration of internal R&D efforts with BD Develop agile and...