Project Manager - Scherzer Lab BWH Neurology at Brigham & Women's Hospital(BWH)

Posted in Other 2 days ago.

Location: Boston, Massachusetts





Job Description:

GENERAL SUMMARY/OVERVIEW STATEMENT:



Precision Neurology Project Manager - Brigham and Women's Hospital, Harvard Medical School


We are looking for a Project Manager for the APDA Center for Advanced Parkinson Research at Brigham and Women's Hospital and Harvard Medical School. The Project Manager will work with the Principal Investigator Clemens Scherzer, MD in advancing precision medicines for Parkinson's and other neurologic diseases. Our program's mission is to develop a participatory, predictive, proactive precision medicine for patients with Parkinson's disease and other neurologic diseases.


The Project Manager will coordinate the APDA Center and operationally lead the Harvard Biomarkers Study at Brigham & Women's Hospital working with Clemens Scherzer, MD. The project manager will have lead role in launching a new clinical initiative designed to identify the contribution of COVID infection, environmental risks, and genetic determinants on cognition in Parkinson's disease.


What we value most in a project manager is a go-getter spirit, energy, attention to detail, organizational skills, and most of all the ability to follow through on short- and long-term tasks and complex projects. The project manager will be relatively independent in executing tasks. An ideal candidate will have an PhD or MD and will have one or two years of experience in conducting human studies or other biomedical science projects. Recent PhD graduates with exceptional qualifications and an interest in Parkinson's disease are encouraged to apply. The project manager will move projects efficiently forward and solve problems along the way. The project manager will motivate and inspire our team members with enthusiasm, kindness, dedication, and impeccable work ethic. Salary will be commensurate with qualifications. Career progression options are available and depending on the project managers successful performance and interests.


Experience with IRB applications, Data Use Agreements, and clinical study coordination are advantageous.


Qualified applicants should email a cover letter, a biosketch, and two letters of reference to Clemens Scherzer, MD at cscherzer@partners.org and to Idil Tuncali at ituncali@bwh.harvard.edu.


This role includes direct supervision of four clinical study coordinators, a biospecimen manager, research fellows and trainees, and a database manager, and guidance of other members, site investigators, collaborators responsible for specific study tasks. This is a senior level position with prior academic or industry experience in clinical trial or clinical biomarker project management and conduct of clinical trials. The incumbent will establish strategic goals and objectives for program development, optimize project work cycles, optimize standard operating procedures, develop and implement policies for clinical research conduct, provide expertise in federal and hospital regulations to the unit, supervise coordinators and other study staff, and will be the source of training, education, and knowledge on clinical trial conduct for the program. The Project Manager will train staff and team members on new regulations, novel issues in study design, ethics, informed consent, confidentiality, sample and data quality control, and other issues that arise with respect to the conduct of good clinical biomarker research. The Project Manager will have full responsibility for IRB amendments and renewals and will liaise with other clinical research units at Partners. The Project Manager will also be responsible for interaction with collaborators, leading collaborative projects through the process, and assembling annual progress reports.



Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:



  • Develop and maintain standard operation procedures for the conduct of clinical biomarker research of the Harvard Biomarker Study per scientific, IRB and FDA guidelines.

  • Serve as primary resource for all regulatory and operational aspects of program projects.

  • Conduct IRB amendments, IRB continuing reviews, IRB reports, maintaining IRB folder including logs of meetings, CVs, lab certifications, MD license documentations, adverse events.

  • Build project plans, and lead study teams to execute plan in compliance with appropriate regulatory guidelines through startup, implementation, and data analysis.

  • Serve as operations leader for all projects supporting the program and ensuring that operational tasks are consistently executed.

  • Train and supervise of staff on the conduct of clinical research.

  • Interface with collaborators and lead collaborative projects with the PI for HBS.

  • Design and launch new clinical research studies, including virtual research visits, utilizing videoconferencing tools and electronic data capture.

  • Organize research symposia and outreach talks for patients as part of the Center for Advanced Parkinson Research, and liaise with other national Advanced Center sites.

  • Create and manage website for the Center for Advanced Parkinson's Research.

  • Design and co-lead Harvard Biomarkers eBrain Study, an extension of the Harvard Biomarkers Study, adapting well-developed protocols and methods to a large, fully-virtual model of clinical and biological data collection nation-wide.

  • Execute Materials Transfer, Non-Disclosure, Data Use, and other agreements.

  • Responsible for obtaining Genomic Data Sharing Certificates, enabling deposition of genetic data in national repositories.

  • Recruit, interview, onboard, and evaluate staff hires for the Harvard Biomarkers Study.

  • Other responsibilities include but are not limited to:

  • Forecast and maintain budgets for projects within the program

  • Assist with grant writing

  • Interact with funding and regulatory agencies

  • Update and improve existing infrastructure for the biomarker program (e.g. update case report forms and other study-relevant documents, database development, biospecimen management, establish data flow/safety monitoring processes, etc).

  • Establish standard best practices for (i) clinical study visits, (ii) sample processing, (ii) data processing, (iv) sample storage and tracking, (v) sample aliquoting and distribution to collaborators.

  • Update standard operating protocols, CRFs, and study protocol

  • Write, edit, publish an annual HBS newsletter.

  • Mentor and assist staff on all issues related to clinical research

  • Analyze of data and prepare reports for publication

  • Conduct ongoing quality assurance audits to ensure research activities comply with applicable regulatory policies.

  • Conduct study visits at peak times in addition to full-time study coordinator

  • Accept responsibilities for special projects as required.

  • Accept temporary fill-in responsibilities for all jobs in the biomarker study as required and as capable (i.e. when the PI is off site, when a study coordinator is on sick leave, during freezer emergency, etc.).


QUALIFICATIONS:



At least four years of prior experience in research. Excellent knowledge of IRB regulations regarding human subjects and clinical research is mandatory. Previous experience in conducting clinical trials, clinical biomarker studies, or human genetics studies is strongly recommended. Experience with RedCap or similar online research instruments is beneficial. Bachelor's degree required; advanced degree preferred.



SKILLS/ABILITIES/COMPETENCIES REQUIRED:



Understanding of clinical research methodology and regulations. Project management and leadership skills, good presentation and writing skills are required. Ability to take responsibility, reliability, exemplary work ethic, and precise implementation are required. We are looking for a person who is fully focused and dedicated to the success of the PNP and our biomarker study. This implies to continuously anticipate and identify any potential issues that can be improved AND to immediately take responsibility to find and implement workable solutions AND to follow-through and verify the problem resolutions. The Project Manager is expected to take ownership in the study and, if necessary, to go above and beyond her/his duties in order to make the study a success. If other team members cannot adequately take care of an issue, the Project Manager will be expected to step in and temporarily take on additional duties as needed for the study's continued success. Ability to lead by example, through motivation and encouragement, ability to interact well with others, take initiative, and think independently required.



WORKING CONDITIONS:



  • Standard office, clinical, and laboratory conditions. Will shuttle several times a week between different study and research sites in the Partners HealthCare system by shuttle or car.


SUPERVISORY RESPONSIBILITY:



  • Will supervise all personnel of the Harvard Biomarkers Study.


FISCAL RESPONSIBILITY:



  • Will be responsible for managing the Harvard Biomarkers Study budget.






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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