Hailey Becker
Functional Manager (Step-up)
Walpole,MA
Summary
Resourceful Manager offering history of success coordinating and monitoring operations across various roles and groups. Effective leader and problem-solver dedicated to streamlining operations to promote organizational efficiency and metrics. Highly committed with hardworking mentality to maintain quality of oversight and engaged employees.
Overview
10
10
years of professional experience
4
4
years of post-secondary education
Work History
Functional Manager Rotation
Janssen Pharmaceutical Companies Of Johnson & Johnson
11.2021 - Current
- Evaluate and project resource needs on an on-going basis.
- Ensure the implementation of clinical studies through efficient allocation of LTMs, SMs and Administrative Associates.
- Ensure close working relationship between other GCO US groups and internal/external business partners.
- Participate in/lead business-related task forces to improve processes.
- Have knowledge of GCO Standard Operating Procedures (SOPs) and fulfill the responsibilities per those SOPs.
- Ensure adequate, timely and compliant monitoring and management of clinical studies conducted in their TA.
- Ensure studies are in a constant state of inspection readiness.
Communicate with staff on program changes, policy changes, and priority shifts on a regular basis. - Be aware of issues affecting staff's workload and efficiency.
Inform supervisor and fellow managers of potential problem situations and work closely on problem resolution. - Ensure staff fulfills roles and responsibilities appropriately and in a timely manner.
- Participate in Management Staff meetings. Conduct staff meetings.
Specialist Site Manger
Janssen Pharmaceutical Companies Of Johnson & Johnson
04.2021 - 11.2021
- Work with 4 sites and 4 study teams on the CAR-T pipeline to ensure that all study milestones and data deliverables are met for assigned sites.
- Maintain quality oversight of sites to ensure inspection readiness at all times. Active use of VIPER & ATLAS reports for SMV preparation and continuous review of KQPIs and other quality indicators (AEs, protocol deviations, SUAs review compliance, TTED, etc.)
- Work with sites facing challenges due to COVID-19 restrictions/ limitations and devise plans to ensure study endpoint evaluations continue to be collected.
- Support other’s development by providing guidance and coaching as a mentor for 3 BRIDGE Site Managers concurrently (5 Site Manager in total). Proactively identify areas of need, consistently provide timely, open and honest feedback to their functional managers.
- Assumed additional responsibilities or special initiatives such as Subject Matter Expert for ATLAS, Site Staff Training and LMS, and Site Specific Deviations groups.
- Participated in the creation of a new system (ATLAS) along with the launch of a new monitoring process for Janssen (Dynamic Site Monitoring) which replaces the ARBM Model. Hosted 7 global training sessions (for upwards of 900 individuals in a single call) as well numerous local sessions post launch. Facilitated several training documents including, but not limited to, the creation and roll-out of Job Aids, manuals, FAQs, role specific videos and visualizations, global guidance documents, and continued global support sessions in the new year.
- Built relationships with MSLs to ensure open lines of communication, taking opportunities where joint interactions at sites make sense for a study in the Boston area. Provide historical performance and information to new MSLs in the region for assigned sites.
- Create opportunities that drive the One Team Culture by collaborating with matrix team members e.g. LTM/CCS/CTM to support trial delivery and realize continuous improvement to operational capabilities in execution and delivery of our pipeline
Senior Site Manager
Janssen Pharmaceutical Companies Of Johnson & Johnson
03.2019 - 04.2021
- Provide strong leadership, process initiative, influencing and mentoring skills.
- May assume additional responsibilities or special initiatives such as “Champion” or “Therapeutic Area Expert”.
- Participate in site feasibility and/or pretrial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
- Act as primary local company contact for assigned sites for specific trials.
- Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Implement of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Work in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contribute to site level recruitment and retention strategy and contingency planning and implementation in partnership with other functional areas.
- Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arrange for the appropriate destruction of clinical supplies.
- Ensure site staff complete data entry and resolve queries within expected timelines.
- Ensure accuracy, validity and completeness of data collected at trial sites
- Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Fully document trial related activities, in particular monitoring.
- Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Collaborate with LTM for documenting and communicating site/study progress and issues to trial central team.
- Comply with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Work closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Prepare trial sites for close out, conduct final close out visit.
Track costs at site level and ensure payments are made, if applicable.
- Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
Site Manager
Janssen Pharmaceutical Companies Of Johnson & Johnson
01.2017 - 03.2019
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- Fully documents trial related activities, in particular monitoring.
- Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
- Attends regularly scheduled team meetings and trainings.
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- Prepares trial sites for close out, conduct final close out visit.
Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- Acts as a point of contact in site management practices.
Clinical Research Associate
PRA Health Sciences
02.2016 - 01.2017
- Designed a WebEx presentation to teach employees foundations of Excel.
- Acted as a Trainer for a phone Pre-Trial Assessment Visit for two employees.
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at
- investigative sites
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP
- guidelines
- Communicates with investigative sites
- Updates applicable tracking systems
- Facilitates audits and audit resolution
- Performs essential document site file reconciliation
- Ensures all required training is completed and documented
- Serves as observation visit leader
Senior Clinical Research Coordinator
Dana-Farber Cancer Institute
05.2014 - 02.2016
- Prepared and led sponsor initiated audit for Phase III Clinical Trial. Clarified any questions the auditors had on site. Was awarded Top Performing Site for an Audit for BMS after audit completion.
- Designed an extensive database and ran reports containing patient specific biomarker test results for the entire disease group. This included continuous follow-up on each individual patient’s sample throughout the 16 week testing process. Aided smaller departments on how to implement and use my database to track biomarker results and helped establish day-to-day tasks to ensure success in their department.
- Arranged, organized, and lead weekly meetings to triage issues affecting the research group. Consisted of the clinical research team, research nurse, research manager, research scheduler, and clinical operations manager therefore optimizing daily operations and procedures for the research group.
- Managed approximately 21 Investigator and Sponsor held protocols for the Head and Neck Medical Oncology group, including IND-held and multi-center trials.
- Maintained all regulatory documentation including informed consent edits (biomarker & optional tumor biopsies), continuing reviews, serious adverse event reporting, FDA submissions, trial master files, and amendments.
- Performed all data entry for all trials managed.
Obtained and shipped specimens (including biomarker, blood, and saliva samples) throughout the trials.
- Lead patient screening and registration procedures. Attended all patient appointments, working collaboratively with medical oncologists to ensure protocol compliance.
- Scheduled all appointments including laboratory tests, imaging, and biopsy procedures.
- Acted as a liaison between the study team, IRB, study sponsors, FDA, pharmacy, and nursing.
- Collected patient samples directly from the OR and Cross Sectional Interventional Radiology for the disease group tissue collection protocols.
- Performed IVRS for protocols and triage any issues pharmacy encountered using the system.
Clinical Trial Protocol Coordinator
Brigham's & Women's Hospital
09.2013 - 05.2014
- Worked on the DECLARE TIMI-58 protocol and provided remote monitoring oversight to approximately 50 trial locations (both nationally and internationally) to ensure compliance for the
TIMI Study Group.
- Managed investigative site compliance remotely via teleconference/web conference
- Oversaw the Patient Retention Application for the entire study, as well as assign action items to
Research Assistants and National Lead Monitors when necessary.
- Tracked and sent escalation letters to National Lead Monitors for Global sites.
- Advise sites on protocol conduct, interpretation of protocols and resolution of issues.
- Work with clinical trial master system to keep track of personnel, regulatory docs, contacts, visits.
- Participated in numerous teleconferences ranging from monthly Global teleconferences, to bi-weekly system and monitoring teleconferences.
- Served as advisor for non-clinical protocol conduct and eCRF completion for sites and evaluate the quality of data, issue and resolve queries, implement corrective action plans, review documentation
for master site files for compliance.
- Ensure compliance with protocol and regulatory requirements.
- Identified issues/trends that require management escalation and provide input to resolution as appropriate.
- Create and send TMF to sites for use throughout the trial with appropriate documentation, and send updates as needed.
Developed source study documents and Newsletters for a Global audience, as well as contributed to the development of Site Management Plans and other related documents/agreements.
- Updated and maintained internal databases, tracking systems and project plans with project specific information. Created master trackers to be used by the team to keep all site and current status of the
trial organized and streamlined.
- Oversaw the site and patient reimbursement process, and prepared presentation materials for meetings (internal/external) and project summary data.
- Trained new and existing employees on protocol and systems used throughout the trial, as well as how to interact with sites on a daily basis.
Research Assistant
Brigham's & Women's Hospital
06.2012 - 09.2013
- Performed injections (Tail vein, Subcutaneous, Intraperitoneal) and tail biopsies on mice
- Performed smoke and allergen inhalation on mice
- Worked as Acting Lab Manager by updating animal experiment protocols for IACUC, proof read/edit grants and papers, and process budget forms for the laboratory. Responsible for ordering chemicals, equipment, and other items needed for the lab to function.
- Supervised the newest technician and high school student, including establishing schedule, training plan, evaluated work completed, and give performance reviews.
- Optimized protocols and procedures for lab members. Instructed new lab members on how to perform difficult animal procedures.Required to maintain over 20 different mouse strains including husbandry and handling (restraints, weaning, sex identification, breeding colony maintenance)
- Genotyped different mice strains
- Trained all employees on how to handle and perform procedures on mice
- Responsible for ordering chemicals, equipment, and other items needed for the lab to function.
- Performed Mucocilliary Clearance Assay in vivo Assay via 3D µSPECT Imaging with Radiopharmaceutical 99mTechnetium-sulfur colloid on Mice
- Performed Bone Marrow Isolation & Transplantation on mice
- Performed Unilateral Urethral Obstruction Survival Surgery on mice
- Performed Protein Assay on mice
- Performed Staining; specifically H & E, Masson’s Tri-chrome, and Immunohistochemistry
- Slide Image Capturing and Analysis for manuscripts
- Performed Polymerase Chain Reaction (PCR) and Real Time Polymerase Chain Reaction (qPCR) on mouse and human samples
- Performed DNA/RNA purification and Gel Electrophoresis
- Performed Streak Plate and Cell Culturing on mouse and human samples
- Performed Neutrophil, Monocyte, and Eosinophil Isolation from blood samples from clinical patients
• Performed Bronchial Lavage Processing (BAL) on clinical samples
Education
Bachelor of Science - Molecular Bio-medical
Bridgewater State University
Bridgewater, MA 09.2008 - 05.2012
Skills
Leadership
Problem-Solving
Cultural Awareness
Computer Skills
Written Communication
Decision Making
Employee training
Training program development
Project implementation
Public speaking
Publications
- Cabozantinib in Patients with Advanced Merkel Cell Carcinoma., Rabinowits G, Lezacano C, Catalano PJ, McHugh P, Becker H, Reily MM, Huang J, Tyagi A, Thakuria M, Bresler SC, Sholl LM, Shapiro GI, Haddad R, DeCaprio JA., Cabozantinib in Patients with Advanced Merkel Cell Carcinoma. Oncologist, Jul 2018.
- Incorporation of next-generation sequencing into routine clinical care to direct treatment of head and neck squamous cell carcinoma., Chau NG, Li YY, Jo VY, Rabinowits G, Lorch JH, Tishler RB, Margalit DN, Schoenfeld JD, Annino DJ, Goguen L, Thomas T, Becker H, Haddad T, Krane JF, Lindeman NI, Shapiro G, Haddad RI, Hammerman PS., Incorporation of next-generation sequencing into routine clinical care to direct treatment of head and neck squamous cell carcinoma. Clinical Cancer Research, 13 Jan
2016., 2016 - Larval ethanol exposure alters free-running circadian rhythm and per Locus transcription in adult D. melanogaster period mutants., S. Tariq Ahmada, Steven B. Steinmetz, Hailey M. Bussey, Bernard Possidente, Joseph A. Seggio, S. Tariq Ahmada, Steven B. Steinmetz, Hailey M. Bussey, Bernard Possidente, Joseph A. Seggio. Larval ethanol exposure alters free-running circadian rhythm and per Locus transcription in adult D. melanogaster period mutants. Behavioral Brain Research, Marc, 2013
Timeline
Functional Manager Rotation
Janssen Pharmaceutical Companies Of Johnson & Johnson
11.2021 - Current
Specialist Site Manger
Janssen Pharmaceutical Companies Of Johnson & Johnson
04.2021 - 11.2021
Senior Site Manager
Janssen Pharmaceutical Companies Of Johnson & Johnson
03.2019 - 04.2021
Site Manager
Janssen Pharmaceutical Companies Of Johnson & Johnson
01.2017 - 03.2019
Clinical Research Associate
PRA Health Sciences
02.2016 - 01.2017
Senior Clinical Research Coordinator
Dana-Farber Cancer Institute
05.2014 - 02.2016
Clinical Trial Protocol Coordinator
Brigham's & Women's Hospital
09.2013 - 05.2014
Research Assistant
Brigham's & Women's Hospital
06.2012 - 09.2013
Bachelor of Science - Molecular Bio-medical
Bridgewater State University
09.2008 - 05.2012