Senior Research Project Manager - Clinical Trials / 40 Hours / Day / BWH Dermatology
Brigham & Women's Hospital(BWH)

Boston, Massachusetts


Workingunder the direction of the Vice Chair for Clinical Trials, and the DepartmentalAdministrator, the Senior Project Manager (SPM) role is a dynamic one,responsible for all activities of clinical trials in the Dermatology ResearchDepartment. This position will proactively manage project level operationalaspects of the Clinical Unit for Research Innovation and Trials (CUReIT)including management of trial timeline, budget, personnel, enrollment and otherresources. The SPM will have theopportunity to oversee cutting-edge industry and investigator-initiatedclinical trials across a breadth of diseases while interfacing withpharmaceutical / biotech experts, research organizations and physicianinvestigators in a multidisciplinary fashion.

Responsibilities:

Will also be responsible for the team's execution on a dailybasis, of the procedural, managerial and policy decisions made for the study.Executes and coordinates daily clinical research activities across a number ofprotocols. Participates in all decisions made for the study and identifiesmodifications of existing policies and procedures. Works across departments andspecialties in multidisciplinary trials. Responsible for budget oversight,training other team members, developing and keeping SOPs current for the unitand participating in supporting grant writing and proposals overseen by thedirector. Oversees the day to day activities of clinical trial coordinator(s),research assistant(s) and CCI/temporary support staff as needed, depending onworkflow fluctuations.

1. Trials operations - The senior project manager is responsible for alloperational aspects of clinical trial oversight including the TIMELY deliveryof every study within budget boundaries. Responsiblefor the coordination and implementation of research design processes and studyprotocols for multiple clinical trials, at multiple sites.

a. Ensuresthat required regulatory documents are completed by the team. Works with the PI and the trial sponsor/contractedresearch organization to complete trial agreements. Communicates effectively and promptly withsponsor contacts and with the PI regarding agreement language. Works to proactively identify issues that maydelay execution of completed agreements. Emphasizes and facilitatescommunication between relevant stakeholders in the pre- and post-enrollment phases of studies.

b. Overseesapplications to the IRB, including new application, amendment, continuingreviews, SAE's, etc. for all new and existing study proposals. Ensures that protocols move through thesystem and receive approval as quickly as possible. Oversees IND and FDAfilings for investigator-initiated studies when appropriate.

c. Workingin concert with the Director, Principal Investigator and/or Clinical TrialsCoordinators, develops and implements patient recruitment strategies. Ensures recruitment goals are met

d. Defines and monitors keyperformance indicators and departmental metrics for Clinical Operations andidentifies opportunities to optimize processes, procedures (SOPs, WorkInstructions) and cost.

e. Provideefficient updates on trial progress to the Director of Clinical Trials,Department Administrator, and/or Administrator.

f. Attendsregular scheduled internal clinical trials meetings as well as any othermanagement meetings at the discretion of the Director of CUReIT and/orDepartment Administrator. Attends orarranges attendance at investigator meetings, if available, together with or inthe absence of a PI, Co-I or other qualified team member.

g. Develops,organizes, and/or maintains the study database. Responsible for data validationand quality control. In conjunction with Principal Investigator, develops andimplements new research protocols including design, data collection systems andinstitutional review board approval.

h. Servesas the primary contact for outside vendors utilized to ensure efficientoperation of the study.

i. Directlyresponds to inquiries regarding study protocol and policy. Serves as liaison to internal and externalpopulation.

i. Mustbe accessible to study participants in order to screen adverse events, concernsand questions related to the investigational drug protocol.

ii. Mustbe easily reachable and 'on-call' (preferably by pager) during assigned workhours to provide study information, screening and, when applicable,point-of-service assistance in carrying out approved protocols.

j. Participatesin all decisions made for the study and the formulation of policies andprocedures. Identifies modificationsneeded and works to implement solutions. Recommends changes to researchprotocols or to unit standard operating procedures. Determinesspecific division of workflow required in each study in order to complete thestudy efficiently, compliantly, and with the welfare and experience of thepatient being the paramount concern.

k. Attendsand participates in investigator meetings, site visits and regular recurringmeetings with trial coordinators and study monitors. Ensures all requireddocuments are ready for any site visit or monitor visit.

  • Financial Responsibilities

  • a. Monitors and reports onthe financial performance of each study.

    b. Reconciles the financialsof every trial each month. Provides PI,Director of Clinical Trials Unit, and Administrator on a monthly basis; reviewsfinancials with team at operational meetings as appropriate. and the rest of theteam with financial reporting

    c. Incoordination with Department Administrator and Grant Administrator, manages thedevelopment and oversight of Unit's budget.

    d. Ensuresall invoiceables are captured and invoiced in a timely manner. Tracks invoices and subject stipends inOnCore and Forte.
  • Human Resources

  • a. Directly managesClinical Unit for Research and Innovation in Trials staff with responsibilityfor staff training, performance management, setting individual employee goalsand career growth opportunities for staff. On a daily basis, ensures the executionof the procedural, managerial, and policy decisions made for the study.

    b. Supervises1-2 Clinical Trials Coordinators, and research assistants, Incumbent isresponsible for making sure they are meeting their job responsibilities and forproviding redundancy and backup when needed.

    c. Maintains,oversees and dictates team responsibilities, with particular focus on regulatoryelements / compliance, timelines, deliverables, and ensuring that we areappropriately managing internal and external delay in the set up process forclinical trials. Troubleshoots delaysand interfaces with complex network of internal and external relevant partiesto effectively execute aforementioned deliverables.

    d. Dependingon the number of clinical trials we have at any given point the ProgramCoordinator may need to function in a CTC capacity at times. This includes allpotential coordinator / RA functions, but is not limited to, initiating andmaintaining contact with study participants, screening applicants / attendingand preparing for trials visits, monitor /site visits, scheduling patientvisits, performing clinical tests such as phlebotomy, EKGs, etc, as well participatingin clinical data collection and obtaining biological specimens.

    e. Holdsregular staff meetings to get reports on current progress in each trial.Reports this progress, successes and delays, to the PI and DA.

    f. Shouldanticipate and make every effort to prevent potential protocol deviations dueto scheduling conflicts, including inability of study staff to be present atscheduled visits (illness, planned vacation, holidays); and arrange appropriatecoverage in advance of aforementioned conflicts.

    g. Maintainsappropriate GCP / CITI, study-specific and other required trainings for allfaculty and staff participating in clinical trials activities. Ensures training for all relevant staff is upto date and in compliance.

    4. Participatesin grant writing, proposal writing and/or manuscript development.

    5. Allother duties as assigned.

    Qualifications
    • Bachelor's degree required. Certification in clinical trials management strongly encouraged.
    • More than 5 years of prior experience in clinical trials (such as prior research coordinator for interventional studies), or relevant employment in industry such as a CRO monitor. Clinical project management experience is preferred.
    • More than 5 years of experience with exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork regulatory paperwork, consenting and interacting with study subjects, strict protocol adherence and archiving are required.
    • Familiarity with working in a large healthcare organization / academic center encouraged.
    • Excellent interpersonal skills are required for working with the study participants and multiple parties involved in the trials process.
    • Supervisory experience is required. Ability to effectively manage individuals at various levels within the team is highly valued. Experience managing a team working across a matrix environment is preferred.
    • Comfort interacting with patients / research subjects and their families in a professional and reassuring manner.

    SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

    • Excellent interpersonal skills are required for working with the study participants and multiple parties involved in the trials process.
    • Flexibility, a strong ability to multi-task, problem-solve and strong interpersonal skills are highly valued.
    • Comfort interacting with patients / research subjects and their families in a professional and reassuring manner.
    • Excellent organizational skills and ability to prioritize a variety of tasks.
    • Careful attention to detail.
    • Ability to demonstrate professionalism and respect for subjects rights and individual needs.
    • Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
    • Certification in phlebotomy or certification within three months is strongly encouraged.
    • Excellent oral and written communication skills.
    • Knowledge of clinical research protocols.
    • High degree of computer literacy.
    • Knowledge of data management programs.


    EEO Statement
    Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.



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