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Clinical Program Manager

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Location
Cambridge, MA
Hourly
$75.00 - $88.00
Job Type
Contract
Degree
Bachelor, Bachelor of Science
Date
May 15, 2017
Job ID
2380096
CLINICAL PROGRAM MANAGER

MUST BE STRONG CLINICAL OPERATIONS BACKGROUND

Clinical OPERATIONS Program Manager position assigned one or multiple compounds and they would be responsible for the clinical operations (planning, execution and oversight of activities)
Working with our PRA Embedded team study execution team to ensure studies and executed and plans are in place to make sure things are on track for timelines and budgets
Cross functional team work within Company and outside of Company (CRO’s)
They will be the clinical operations lead coordinating the different activities on the program 
Providing strategic direction on the operational plan to the study managers- will not directly line manager study managers but will oversee their work in terms of the project
Must be LOCAL candidates. Manager wants someone on-site.
There is flex to work from home 1 day a week, but they need someone on-site ASAP.

Must have experience within a CNS therapeutic area within pharma/biotech
Bachelors required
Experience is mid level, they need to have a number of years of doing this before. 
Need to have worked independently.
Clinical Project Manager
 
Ideally, candidates must have sponsor experience so someone who can oversee small CRO and a Large CRO. They run Global trials in the US and Taiwan, Hong Kong and China, (not travel to these places) minimal travel to meetings and functions down in NJ and want someone who is flexible if they need them to visit a site investigator but again. They should understand the pre-clinical side of things so they can interact with those folks. They have protocols in place but someone who has written or developed protocols is always "good since they will understand". If they have experience with INDs/ NDAs that is also great. They are doing Phase 1-3 trials in  oncology and are exploding!!!
 
The Clinical Project Manager (CPM) will work in a matrix management environment and serves as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee CRO conduct and progress when outsourcing is required. The CPM understands all aspects of project management and ensures that the study meets projected milestones within budget. The CPM may assist the director in managing and implementing project management team meetings.
 
Essential Job Requirements
.     Coordinate the standardization and maintenance of status reports and
other information sources.
.     Facilitate communication with external partners and key therapeutic
area investigators when issues arise that affect multiple projects and/or TA(s).
.     Work with project leadership to facilitate cross-functional team and
multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues.
.     Participates in the development of risk mitigation strategies.
.     Coordinate with project leadership to identify and notify
appropriate parties of emerging out of scope activities.
.     Participate in the development of the protocol, protocol revisions
and amendments, monitoring plan, scope of work and operational processes.
.     Provide input into the development of the CRF (data capture forms)
design and completion instructions.
.     Collaborate with the TA(s) management staff & cross-functional
management teams, in development of budgets and timelines for new studies.
.     Performs ongoing vendor management (e.g. CROs, IVRS) including
independent negotiation of vendors scope of work and budgets, performance management and issue resolution.
.     Ensures accuracy and timeliness of vendor and site payments.
.     Perform activities of Lead CRAs (Senior CRA and other monitoring
staff) on a temporary basis as needed to move project deliverables and timelines forward.
.     Provide expertise in managing sites and clinical monitoring
activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
.     Review visit reports and escalate issues to medical and operational
leaders.
.     Ensures trial adherence to ICH/GCP/local regulations.
.     Calculate clinical and non-clinical IMP requirements.
.     With cross-function departments to ensure timely manufacture,
packaging and IMP shipment to sites.
.     Facilitate SAE medical review process.
.     Assist medical and project leaders with safety reporting compliance.
.     Coordinates data cleaning activities.
.     Reviews query aging reports against timeline and works with
functional team members or CRO to resolve queries according to plan.
.     May review clinical data (listings and tables)
.     Have an understanding of IND/NDA submission requirements.
.     Assist with the review and revision of new and revised IND
documents.
.     Conduct quality control (QC) audits on annual and ad hoc IND
updates.
.     Serves as functional manager for contract study monitors
 
Desired Qualifications:
.     Bachelor of Science (applied science) or registered nursing degree
(Masters preferred).
.     At least three years of experience in Clinical and Project
Management.
.     Excellent Project Management skills.
.     Direct and positive experience communicating with Clinical
operations team and study sites.
.     Must have excellent organizational skills and work effectively in a
fast paced environment.
.     Must possess good analytical and researching skills.
.     Must be proficient in Microsoft Word, Excel, Office and MS Project.
.     Ability to education and train junior staff.