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 Job #02618 Email this job to a friend
About our client
Our client is a rapidly growing pharmaceutical company headquartered in Maryland that focuses on the development of products in the areas of allergies, oncology, inflammation and infectious diseases.
Position Location
Clinical Project Manager Maryland
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Provide guidance and oversight for the successful management of all aspects of US and International clinical trials within designated program budgets and timelines
2) Develop and monitor study budgets and timelines
3) Partner the functional peers to manage, adjust and revise project timelines and budgets (as necessary)
4) Handle various tasks like developing proposals, selecting contractors and managing external resources
5) Communicate project status and issues to the management and other team members
6) Ensure that project team goals are met
7) Participate in the development of SOPs, protocols, investigator brochures, INDs, clinical study reports and other clinical, regulatory and safety documents
8) Contribute to the development of abstracts, presentations, manuscripts and other external forms of communication
9) Recruit, hire, mentor, manage and supervise CRAs and other Direct Reports to support their professional development
10) Participate and coordinate various training activities
11) Develop, implement and complete clinical trials
12) Manage designated program budgets and timelines
13) Determine activities that are critical to the company’s success and priorities within the functional area
14) Anticipate obstacles of varying complexity and implement solutions to achieve project goals
15) Lead strategic initiatives
Requirements
1) Bachelor's degree in a relevant scientific discipline
2) Minimum 6 years of relevant clinical trial experience in the pharmaceutical or biotech industry
3) Experience in West Nile virus and psoriatic arthritis preferred
4) Experience in managing staff as well as mentoring and developing junior staff
5) Experience in EMEA regulations beneficial
6) Experience in developing proposals and selection and management of vendors and contractors
7) Experience in Microsoft Word, Power Point and Excel
8) Expertise in initiating, authoring, or contributing to SOP development, implementation and training
9) Knowledge and understanding of FDA regulations and GCPs governing the conduct of clinical trials
10) Self-starter with an ability to manage multiple projects
11) Ability to successfully implement and manage a complete clinical trial

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