#BIOTECH PROJECT MANAGER RESUME REGISTRATION#
#BIOTECH PROJECT MANAGER RESUME TRIAL#

Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.

#BIOTECH PROJECT MANAGER RESUME TRIAL#

Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met.

#BIOTECH PROJECT MANAGER RESUME REGISTRATION#

Your main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration

Successful experience in working with globally operating matrix teams and in the coordination with various internal and external interfaces (academia, in-house labs and contracted vendors)Ĭlinical Scientist for Phase I/II including multi-country / multi-center trials.

Understanding of the vaccine development process and experience with the support of clinical trial teams.

Basic understanding of GMP, GCP-ICH and GCLP guidelines.

flavivirus, alphaviruses, calicivirus) and vaccine development is desirable, as well as in immunology and molecular biology

Strong communication, strategic, analytical problem-solving & interpersonal skills.

Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).

Understanding of the vaccine development process and experience with the support of clinical trial teams

Basic understanding of GMP, GCP-ICH and GCLP guidelines.

flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology This includes experience and understanding in working with blood borne pathogens and human serum

Experience and demonstrated success in the development and, validation and clinical sample testing by using serology assays and other bio-analytical methods.

Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Interact with investigator sites and CRAs/CROs/vendors to ensure a smooth study set up and a smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Track record of successfully managing multiple concurrent global phase I and IIa, multi-country/site complex clinical trials.Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents.Business-level written and oral English.Used to working independently and in a team environment, being flexible and adapting to change.Used to working independently and in a team environment, being flexible and adapting in a changing environment.Responsibilities for the BioTech Project Manager: - Lead day-to-day project management tasks to ensure success of projects - Offer hands-on assistance in PD and cGMP operations determined by Management - Ensure that financials and program milestones are aligned Requirements for the BioTech Project Manager: - Bachelor's degree in science related field - Experience within a GMP environment and/or Pharmaceutical or Biotechnological organizations - Experience with change orders, invoicing, or payment activities Compensation for the BioTech Project Manager: - Salary: $70k- $135k Based Upon Experience - Benefits: Health, Dental, & Vision insurance, and 401K Salary Range: $100K - $150K Minimum Qualification Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications. This position will be in a HYBRID style schedule. Piper Life Science Solutions is currently seeking a motivated BioTech Project Manager in the Rockville, MD area to a leading organization in vaccine development.

Biotech project manager resume