Dr.Manasi Musale
Dallas,TX
Summary
- Organized and dependable physician, successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
- Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
- Several years of experience conducting research to study human diseases and drive healthcare improvements. Investigative professional leading clinical research to support diagnosis and treatment of diseases. Critical thinker with background developing and improving methodologies and procedures for superior data reporting.
Overview
16
16
years of professional experience
Work History
Medical Affairs Manager
Philips Healthcare
12.2017 - Current
- Manage timelines, budget, and deliverables
- Management of transitions; in-house safety activities with CROs
- Manage and lead Safety personnel
- Training, mentoring, and onboarding newly hired safety personnel
- Manage CEC: onboarding, budget, training, time management
- Timely management of publication data
- Lead safety contact for medical inputs
- Author study and safety related documents
- Inputs and edits on Safety related documents, SOPs
- Leading safety meetings with key stake holders, clinical teams etc
- Overseeing the development and implementation of safety program initiatives, process improvements and sound safety principles and practices
- Leading assigned studies within the study timelines and always meet the deliverables
- Working closely with CROs, data management and clinical team to meet timelines
- Oversee process/review/evaluate/ and track adverse events
- Ensure timely reporting of AE’s SAE’s and UADE’s including expedited and safety input into annual reports and other documents as needed
- Actively participating in working groups for development and improvement on department level to increase productivity
- Developed and updated policies and procedures, maintaining compliance with statutory, regulatory and local, state and federal guidelines relating to HIPAA, benefits administration and general liability.
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
Sr. Clinical Research Specialist/ Clinical Safety Manager
Abbott
05.2017 - 12.2017
- Managed and oversaw the overall process for safety-related tasks
- Responsible for Start-up Safety group
- Actively participated in safety acquisition during the merger
- Managed timelines and deliverables for the Safety team
- Budget for clinical study project
- DSMB/CEC: Oversaw selection, contracts, physician trainings, pre-study start-up meetings
- Managed Pre- and Post-market Studies
- Maintained Study from Start-up to Closure: study progress, follow-up, training, and resolution with sites/monitors etc
- Provided safety review of clinical study documents including protocols and study reports
- Determined study objectives and Safety endpoints
- Updated the Study SOPs & related documents in accordance with Compliance, GCP & ICH
- Aligned and added study & safety Processes
- Evaluated clinical data
- Successfully initiated areas in studies needing improvement, which resulted in significant cost savings and timely delivery
- Time management/Priorities and deadlines: Coordinated activities of clinical and cross functional teams
- Preparation of Reports- for trending, FDA submissions, publications, upper management meetings etc
- Interim reports: interpret, evaluate, analyze the clinical data
- Managed/updated the Quality documents
- Closely collaborated with Quality, Regulatory authorities, and various cross-functional teams
- Clinical Safety Reporting as per the US & International standards
- Medical/scientific consultant for internal team, government regulatory agencies, NCAs
- EU report submissions to NCA
- Provided input on (CIP) Study Protocol, Data Management Plan, Study Management Plan and Monitoring plan etc
- Clinical Evidence Strategy: End-point research for Upcoming Studies
- Attended scientific and medical device conferences to keep up with the latest trends and medical research
Global Safety Lead - Clinical Safety Specialist
Medtronic
10.2013 - 04.2017
- Review and triage of clinical trial deaths and AEs including SAEs for assigned studies
- Conduction of the case management in the Clinical Safety Database
- Global Safety Lead on cardio-vascular and respiratory studies
- Served as MD on Internal MDT CEC to adjudicate AEs trial program
- Contribution to clinical sites/monitors training and liaison for safety-related questions
- Interaction with investigational sites and field monitors to obtain additional pertinent information as needed
- Work with the clinical project team to ensure consistency in the assessment, recording, and coding of clinical safety events
- Ensure appropriate distribution and notification of SAEs and UADEs to appropriate personnel
- Managing timely reporting of AEs, SAEs and UADEs to Clinical Operations and Field Assurance
- Able to work with Global team, manage and prioritize multiple tasks
- Managing independently and with various partners/teams to bring the study to successful completion
- Author Clinical Safety plan, Clinical Event Committee (CEC) charter etc
- Collaboration with data management and other departments on the development of study specific safety reports and other study-specific forms, CFRs etc
- Conduction of study-specific trending
- In-person training of new clinical safety personnel, CEC MDs, site monitors, principal investigators etc
- Knowledge of GCP, ISO14155:11 compliant definitions, and/or regulatory compliance guidelines for trials
- In accordance with Safety quality documents/SOPs etc.
Field Associate
06.2013 - 09.2013
- Prepared, conducted and implemented food research projects following established protocols
- Recorded research procedures and results ensuring quality and integrity of the research data.
Biometric Screening and Health Coach
Accountable Health Solutions
04.2012 - 09.2013
- Managed the whole project with direct reports
- Conducted Health and Nutrition assessments and consultation
- Lab assessments, on the spot medical consultations based on test results.
Research Assistant
University of Minnesota – Pediatric Research
12.2012 - 06.2013
Physician
Ruby Hall
01.2006
- Recommended tests analyzed the results, along with careful physical examinations, to properly arrive at a diagnosis, and treated it
- Managed the staff, with direct reports
- Examined and maintained patients’ medical history
- Every morning conducted rounds in the wards with nurses, clearly communicated with the patients on the updates in their recovery
- Educate patients with their diagnosis & treatment plans
- Whenever needed, communicated with their relatives on further treatment plans, Physician shadowing- Cardiology, Obs
- Gyn., General surgery, Pulmonology, Dermatology, Endocrinology, Neurology
Consultant Pediatrician
Children’s Govt. Hospital of Tver and Private Practice
01.2006 - 01.2008
- Monitored childhood developmental markers such as weight, height and blood pressure to screen for abnormalities
- Administered required vaccinations and advocated for adherence to vaccination schedule for best disease prevention.
- Provided yearly physicals, sports physicals, and immunizations to children.
- Met with new parents and parents-to-be to inform and educate on care of newborns.
- Diagnosed and treated patients suffering from chronic conditions.
Physician, Pediatrician
01.2003 - 01.2006
Jehangir Hospital
1 1 - 1 1
- Consultations in various specialties.
Education
M.D. - Pediatrics
Tver State Medical Academy
Skills
- Experienced Physician with several therapies/treatments
- Study Management for Medical Device
- Pharmaceutical & Drug Safety development
- People Management skills
- Author Safety/CEC/DSMB documents
- Training Investigators and sites
- Past experiences with Structural Heart -Valves
- Cardio stents
Affiliations
Medical Council of India, India
Ministry of Health, Russian Federation, Russia
Languages
English
Native or Bilingual
Russian
Full Professional
Timeline
Medical Affairs Manager
Philips Healthcare
12.2017 - Current
Sr. Clinical Research Specialist/ Clinical Safety Manager
Abbott
05.2017 - 12.2017
Global Safety Lead - Clinical Safety Specialist
Medtronic
10.2013 - 04.2017
Field Associate
06.2013 - 09.2013
Research Assistant
University of Minnesota – Pediatric Research
12.2012 - 06.2013
Biometric Screening and Health Coach
Accountable Health Solutions
04.2012 - 09.2013
Physician
Ruby Hall
01.2006
Consultant Pediatrician
Children’s Govt. Hospital of Tver and Private Practice
01.2006 - 01.2008
Physician, Pediatrician
01.2003 - 01.2006
M.D. - Pediatrics
Tver State Medical Academy
Jehangir Hospital
1 1 - 1 1
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