Clinical PM

Position Summary:

Provides clinical support an******** for diagnostic product developmentto achieve clearances an******** in the US an********. Manages theplann******** implementation an******** of multiple clinical trials incollaboration with the project team to meet study enrollmen********testing an******** timelines per applicable regulatory re********protocol, Goo******** Practices (GCPs) an******** operating procedures(SOPs). Rev******** assesses an******** data clinical studies an********le********. Oversees an******** clinical project personnel and/orconsultants. Conducts clinical compliance activities. Manages clinicalstudy budgets. Provides supervision and/or guidance to other clinicaldevelopment personnel. May be responsible for multiple clinical studies.

All About You


Responsibilitie********

Management of clinical trial projects including development of projecttimelines (utilizing Microsoft Project software), study bu********an******** plans. Reports project status to senior management.

• Participate on product development core teams as the clinicalrepresentative.
• Lea******** sub-teams an******** sub-team activities to core team.
• Responsible for identifying an******** investigators. Buil********with clinical sites.
• Work with business development to contract external s********consultants, ven******** contract research organizations (CROs), etc.
• Manage activities performe******** consultants, CROs an********including initial identification of a suitable partner, definition ofrespons******** preparation of communication plan, defining division ofrespons******** monitoring of milestones an********, review of monthlystatus reports, an******** management to ensure project success.
• Write and/or review trial relate******** (protocols, case reportforms, consent ******** letters of agreement, confidentialityagreements).
• Submit protocols to IRB/EC, assist clinical testing laboratories withIRB/EC subm******** an******** collection an******** of require********study documents an********.
• Ensure adequate monitoring of study is conducte******** clinicalsub-team.
• Rev******** assess, an******** data from ongoing an********stu******** an******** reports as required.
• Write and/or review clinical sections of regulatory submissionsan******** labeling an******** compliance with applicable regulations.
• Writes abstracts, papers, an******** relate******** study results asrequired
• Responsible for the oversight of the ongoing maintenance of the TrialMaster File
• Participate in the conduct of internal an******** audits an******** ofclinical studies.
• Monitor compliance with all company standar******** procedures (SOPs),GCP, FDA an******** international regulations concerning clinicalactivities.
• Comp******** review an******** device complaints. Ensures correctiveaction is taken, as needed.
• Review all unanticipate******** device effects (UADEs), ensure medicalreview an******** requirements are met.
• Manage multiple clinical studies in parallel, through direct reportsand/or other support staff, as appropriate
• Perform personnel relate******** duties as appl******** includingselect******** ******** an******** evaluation of personnel to ensure theefficient operation of the team.
• May manage a team of clinical development professionals. Mentor juniorstaff including those that are not direct reports.
• Create an******** departmental procedures (including projectmanagement processes an********) in compliance with industry standardsan******** requirements.
• May provide input an******** for post-clinical activities an********launch of product.
• May participate in organizational initiatives.


Requiremen********

• 5+ years functional experience with managing clinical tr********including risk assessment an******** planning.
• Industry experience within in vitro diagnostics (IVD) needed; medical******** pharmaceut******** or biologics experience can substitute inpart for IVD experience.
• Data management experience highly desirable.
• Knowledge of statistical principles as applie******** clinical trialshighly desirable.
• Thorough knowledge of GCP, ICH guidelines an******** US an********clinical regulatory requirements.
• Demonstrate******** to work independently with new, complextechnologies an******** professional work products.
• Strong written an******** communication skills; demonstrate******** toorganize an******** scientific information (e.g., clinical studyresults) to internal an******** audiences.
• Supervisory an******** leadership skills highly desirable.
• Familiarity an******** to work with office automation programsan******** database tools.
• Strong work ethic an******** ability to deliver assignments on time.
Education:

• Bachelor’s degree or equivalent in the life sciences or relate********required; advance******** (Master’s or above) preferred.

Additional coursework in clinical trial planning an******** stronglydesired.