Balashowri Moulika Singam
Damstadt,ENG
Summary
Experienced in Clinical Research with focus on study planning, data collection, and trial management. Familiar with regulatory guidelines and clinical procedure oversight. Strong communication skills coupled with ability to manage multi-faceted projects effectively contribute to comprehensive execution of clinical research studies. Previous work has demonstrated significant improvements in efficiency and accuracy of data collection processes. Detail-oriented and well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
ICON Clinical Research
Langen, Hessen
11.2024 - Current
- Advanced to Clinical Research Associate, handling intricate studies.
Clinical Research Associate I
ICON Clinical Research
Langen, Germany (Remote)
11.2023 - 10.2024
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted qualification, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Closed queries and issues in accordance to timelines and supported sites in maintaining compliance with protocols.
Study Startup Associate
ICON Clinical Research
Langen, Germany
07.2023 - 10.2023
- Managed legal entity change process in DACH region, including document collection, preparation, review, approval, and regulatory processing.
- Maintain a comprehensive and organized document management system.
- Collaborate with internal and external stakeholders, to obtain necessary approvals and ensure timely completion of document-related activities.
Intern Therapeutic Areas
Boehringer Ingelheim
10.2020 - 12.2020
- Streamlined disease awareness campaign through content editing and efficient team meeting organization
- Consistently met deadlines ahead of schedule
- Collaborated with cross-functional teams to deliver customer-centric content
- Resulted in increased customer engagement
- Managed digital assets with 95% accuracy
- Reduced duplicate and outdated content by 20%.
Marketing internship
Boehringer Ingelheim
03.2020 - 08.2020
- Researched successful pharmaceutical launches in rare disease domains, focusing on patient centricity
- Identified issues in product launching and analyzed potential obstacles
- Provided innovative solutions for patient-centric drug launches in rare disease fields
- Demonstrated creativity and resourcefulness in implementing patient-focused clinical trial designs.
Integrated project
Eli Lilly
01.2020 - 02.2020
- Analyzed problems related to mobility as a service
- Collaborated with the team to develop effective solutions
- Conducted extensive research and analysis to gather insights
- Presented implementation plan to higher management
- Contributed to improving the mobility service offerings.
Intern in Talent, Leadership & Org. Effectiveness
Boehringer Ingelheim
11.2019 - 02.2020
- Researched and analyzed corporate-university relations and BI's employer brand
- Provided improvement suggestions for university outreach efforts
- Managed global LinkedIn content and tracked feedback
- Supported survey launches in multiple German locations.
Associate General Dentist
RR Super specialty Dental Hospital
03.2018 - 08.2018
- Conducted dental consultations and explained treatment plans
- Performed extractions, root canals, and cavity fillings with focus on pain management
- Developed personalized treatment plans
- Interpreted radiographs for accurate diagnoses.
Education
Master of Arts - International Healthcare Management
Accadis Hochschule Bad Homburg
Bad Homburg vor der Höhe01.2023
Bachelors of Dental Surgery -
College of dental sciences, RGUHS
Davanagere03.2017
Secondary high school -
NRI Academy
Guntur03.2011
Secondary school -
GKR public school
Guntur03.2009
Skills
- Clinical Trials Management
- Site Management and Monitoring
- Agile Project Management
- Good Clinical Practice
- Drug Development
- Data Management and Data Collection
- Electronic Data Capture
- ICH Guidelines
- Coordinating site operations
- Informed Consent Process
- Clinical Documentation
- Completing regulatory documents
- Case Report Forms
- Source Document Verification
- Team Training
- Drug Accountability
- Pharmacovigilance and medication safety
- Effective communication
- Team player and Collaboration
- Adaptability
- Critical thinking and Problem solving
- Quick Learner
- Time Management
- Emotional Intelligence
- Strategic Planning
- Strong Organizational Skills
Certification
- Board Certified Medical Affairs Specialist (BCMAS), ACMA, 04/2023
- Clinical Trials Management and Advanced Operations, Certificate in Good Clinical Practice, 05/2023
- Pharmaceutical Regulatory Affairs, Certificate of completion, 04/2023
- Regulatory Compliance Inspections and External Audits, From GxP Training, 05/2023
- Clinical Research, Certified Course (CCCR), 05/2023
- Project Management- Healthcare projects, Certificate of completion from LinkedIn, 04/2023
- Advanced Agile: The Team's Mindset, 05/2023
- Developing Your Emotional Intelligence, 05/2023
Timeline
Clinical Research Associate II
ICON Clinical Research
11.2024 - Current
Clinical Research Associate I
ICON Clinical Research
11.2023 - 10.2024
Study Startup Associate
ICON Clinical Research
07.2023 - 10.2023
Intern Therapeutic Areas
Boehringer Ingelheim
10.2020 - 12.2020
Marketing internship
Boehringer Ingelheim
03.2020 - 08.2020
Integrated project
Eli Lilly
01.2020 - 02.2020
Intern in Talent, Leadership & Org. Effectiveness
Boehringer Ingelheim
11.2019 - 02.2020
Associate General Dentist
RR Super specialty Dental Hospital
03.2018 - 08.2018
- Board Certified Medical Affairs Specialist (BCMAS), ACMA, 04/2023
- Clinical Trials Management and Advanced Operations, Certificate in Good Clinical Practice, 05/2023
- Pharmaceutical Regulatory Affairs, Certificate of completion, 04/2023
- Regulatory Compliance Inspections and External Audits, From GxP Training, 05/2023
- Clinical Research, Certified Course (CCCR), 05/2023
- Project Management- Healthcare projects, Certificate of completion from LinkedIn, 04/2023
- Advanced Agile: The Team's Mindset, 05/2023
- Developing Your Emotional Intelligence, 05/2023
Master of Arts - International Healthcare Management
Accadis Hochschule Bad Homburg
Bachelors of Dental Surgery -
College of dental sciences, RGUHS
Secondary high school -
NRI Academy
Secondary school -
GKR public school
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