Clinical Research Senior Project Manager Psychiatry

Clinical Research Senior Project Manager Psychiatry-(3294990)

Description

The Division of Addiction Psychiatry islookingforadynamic and detail-oriented Senior Clinical Research Project Manager who possesses a growth mindset tohelpsupport the development of our lab.

Under the general direction of the Division Senior Administrator and the Division Director and Principal Investigator, the Senior Clinical Research Project Manager willhave responsibilityforday-to-day and long-term strategic management related to the research conducted within the division and development of the lab operational structure to support continued growth and innovation.

This is a unique opportunity to support a lab during a period of growth and implement a structure that will support additional development.

The Senior Project Manager will have oversight of day-to-day lab operations, all research activities, regulatory management, training, onboarding, and hiring of staff, communication between project teams, and research budgets.

Responsibilities will include, but not limited to, ensuring research project deliverables arecompleted ina timely manner, ensuring seamless communication across project teams, working with the PI to manage research related tasks and delegate responsibilities to the research coordinators and interns / students / trainees,managingregulatoryactivitiesassociatedwith research studies, IRB submissions and renewals, assembling grant applications, and communicating with or submitting applications to FDA, DEA, trial registry, or other regulatory agencies.

Well-developedorganizational,communicationand strategic problem-solvingabilities suitableforafast-pacedresearchenvironment are required.

The idealcandidate must exhibit a high levelofexpertise, comfort, andindependence inmanaging and facilitating objectives for a complex cross-functionalproject team that spans Mass General Brigham and external collaborations.

Previous experience with project management in the field of research and a history of completing projects to specification is required.

Qualifications

Qualifications

PRINCIPAL DUTIESANDRESPONSIBILITIES :

ProjectDefinitionandTracking

• Responsibility for all aspects of project direction and administration
• Workcloselywithlabmemberstogainanunderstandingofdataprocessingmethodsandtools.
• Documentsandfacilitatesthedefinitionofprojectscope,goals,andresourcerequirements.
• Translatesclearlydefinedprojectneedsintodeliverables, milestones,andtimelinesbyestablishing the project plan.
• Tracksprogress ofkeymilestones, ensuringexecutionofkeydeliverables.
• Manageschangesintimelines,deliverables andbudgetasneeded.
• Workscloselywithprojectleaderstoestablishqualitycriteriaandmonitorqualityofprojects.
• Conductsprojectevaluationsandassessmentofresults.
• Activelyseeksoutbestpractices; transmitsthisinformation totheprojectteamandrevisesprojectplan accordingly.
• Develops timelines,tasklists,andoperationalplansforthecompletionofresearchprojects,grant deliverables, and laboratory management goals incoordination with the principal investigators.

Communication / Reporting

• Ensuresappropriatecommunication withallprojectstakeholdersregardingtimelinesandstatus,deadlines, data requirements, logistics and all other project-related issues.
• Facilitatesprojectmeetingstocontinuallyaligntheteamaroundgoalsandcommunicate blockingissues.
• Serves as a spokesperson for the study, when needed.
• Prepares project reports for the NIH

Compliance

• Ensuresappropriatefundsareinplaceandtracksfinancialstatusofallprojectsrelativetoavailable budgets
• WorkswithCompliance officetogenerateandmaintainappropriate IRBforworkspecific toprojectplan(if necessary).
• Ensuresthatprojectsandactivitiesadheretoinstitutional guidelines withregardstosafetyandregulatory compliance.
• Work closely with department research administration, Research Management and the Clinical Trials Office to ensure compliance with all local and federal regulations for all NIH, industry, foundation, and industry funded trials.

ManagementandTeamwork

• Project management ofrecruitment efforts, data and sample collection for patients enrolled instudies, and coordination and scheduling of study visits at Center for Clinical Investigation sites.
• Responsible for all HR issues on project. Oversees hiring, firing, evaluation, discipline, training and orientation of all staff.

Has overall responsibility for supervision.

• DelegatestaskstoClinicalResearchCoordinators
• Schedules, leadsanddevelopsagendasandminutesformeetingsrelatedtoongoingprojects.
• Identifiesroadblocksandalternativestrategiesforthecompletion ofprojectson-timeandtospecificationand communicates updated information onat-risk deliverables ordeadlines tothe principal investigator(s) and other research staff.
• Developsprotocoldocuments needed for IRB or other regulatory agenciesthatmeetfederal / institutionalstandards.
• Ensuresstudydesign'scompatibilitywithclinical / researchpractices.
• Providescriticalinputastofeasibilityofstudydesignandavailableresources.
• Ensuresdocumentconsistency and compliance with all relevant regulations.
• Attendsmeetingsandscientificconferences,asneeded.
• WorkswithClinicalResearchCoordinators and / or biostatistician or their equivalent toperformdataaudits,including qualitycontrolandassurance of research data, as need.
• Assistswithpreparationofgrantapplications andmanuscripts, includingdataanalyses,literaturesearches, drafting of text, confirming affiliations, andlinking of funding to accepted manuscripts.
• AssistswithMaterialTransferAgreements,DataUseAgreementsandResearchCollaborationagreements.
• Maintainscommunicationplatformsincludingnewsletters,emails,andlabwebsites / socialmedia.
• Assistswithdatacollection,interviews,dataanalysis,andreportingofpreliminaryfindings,asneeded

QUALIFICATIONS :

• MA / MS / MPH or MA in a related field required.
• 7+ years of progressively more responsible experience in a research environment required.
• Supervisory experience required.
• Experience with financial management of research funding strongly preferred.
• Experience with National Institute of Health (NIH) research grants, strongly preferred .
• Experienceandtraininginprojectmanagementorprogrammanagement required, PMP a plus.
• Experienceinclinicalresearch, psychiatric or substance use disorder research, preferred.

SKILLS / ABILITIES / COMPETENCIESREQUIRED :

• Demonstrated abilitytowork withacrossfunctionalcollaboration toeffectivelymanageanddeliveronproject goals.
• Abilitytoadaptplansandprioritiestorapidlyshiftinggoals.
• Mustpossessahighlevelofinitiativeandtheabilitytoworkindependently,aswellasinateamenvironment.
• Knowledgeofprojectmanagementtechniquesandtools.
• Excellent communication skillsrequired; theabilitytoeffectively communicates information andinfluence others.
• Excellenttimemanagement,interpersonal,andorganizationalskillsrequired.
• Mustbeablehandleavarietyoftasksandeffectively solveproblemsastheyarise.
• Excellentinterpersonal / communicationsskills.
• Abilitytomakeindependent,effectivedecisions.
• Excellentjudgementandabilitytointerpretinformationandprotocolrequirements.
• Aptitudefortechnicalproblemsolving.
• Exceptionalorganizationalskillsandabilitytoorganizetimeandprioritieseffectively,askingfordirection when appropriate.
• Flexibility tohandlemultipletasksanddeadlinepressures.
• Abilitytoidentifyissuesandinitiatesplanstoaddress; Demonstratesforthrightnessandintegrity.
• Skillstoworkefficiently andeffectively andstrivestodosoinallaspectsofposition. Abilitytoengender these skills among staff.
• Abilitytohandlesensitiveandconfidentialmattersdiscreetlyandtoensure confidentialityguidelines are maintained by staff.
• Abilitytoappropriately evaluateallaspectsofasituationandtoindependently makeappropriate andtimely decisions.
• Exceptionalcomputerskills(includingoperatingsystems,wordprocessing,database,electronicmail, Internet, and spreadsheets).
• Knowledge inallaspectsof research safetyandabilitytoensureasafeenvironment forlaboratory staffand subjects.
• Abilitytowork withlargegroupsofinvestigators acrossdepartments / centersandinstitutions tocomplete project deliverables.
• Innovative,detail-orientedandself-motivated.

SUPERVISORYRESPONSIBILITY :

Managementof lab staff such as clinicalresearchcoordinators, biostatisticians, and interns / students / trainees.

FISCALRESPONSIBILITY :

Fiscalresponsibilitieswillincludebudgeting and expense management forprojects,identifying cost-effectivestrategiestocomplete projects, and ensuring lab consumables are obtained at best rate possible.

WORKING CONDITIONS :

• Hybrid;officeand clinicalenvironment
• Somelocaltravelmayberequired.
• Someafter-hoursmeetings mayberequired.
30+ days ago