High-performing clinical trial manager with over 24 years of experience in clinical operations, regulatory affairs, and data quality management. Proven ability to lead diverse teams and manage clinical trials across various therapeutic areas, ensuring efficient operations and compliance. Expertise in collaborating with global resources to enhance study execution and drive successful outcomes.
Hi, I’m
Surya Nakkella
Chester Springs,PA
Summary
Overview
24
years of professional experience
Work History
Johnson & Johnson-Janssen R&D LLCSpring House
Sr. Clinical Trial Manager
01.2012 - Current
Job overview
- Led clinical trials across multiple therapeutic areas, resolving bottlenecks with timely solutions.
- Fostered effective cross-functional collaboration, ensuring adherence to finalized timelines.
- Built strong relationships with local teams, delivering high-quality data for global approvals.
- Provided performance feedback on vendors interfacing with CTMS and proposed mitigation strategies.
- Contributed to development of departmental procedures and templates for continuous quality improvement.
- Oversaw role clarity tool, streamlining distribution of CTM tasks among vendors and countries.
- Managed transitions through various trial stages, ensuring appropriate staffing throughout lifecycle.
- Mentored new clinical trial managers, facilitating onboarding and preparation for their roles.
Bristol Myers SquibbLawrenceville
Clinical Scientist (Cardiovascular, Metabolic, Oncology)
02.2010 - 12.2011
Job overview
- Led operational aspects of early phase clinical studies, ensuring high-quality delivery under tight timelines.
- Co-authored moderately complex study protocols to support global clinical trials.
- Developed recruitment strategies, selected quality sites, and conducted feasibility assessments.
- Created case report forms to facilitate data collection and analysis.
- Ensured thorough data review processes with effective query generation and resolution.
- Received multiple ‘star’ awards for successful leadership in four proof of concept studies.
- Proactively developed risk management plans to mitigate study-related issues.
- Tracked site and country-level enrollment continuously, collaborating with SS&P on contingency plans.
Johnson & Johnson - CentocorChesterbrook
Global Trial Management Associate (Pulmonary)
10.2008 - 01.2010
Job overview
- Tracked and reported study progress while organizing international investigator meetings.
- Reviewed ICFs, HIPAA forms, Canadian privacy consents, and patient recruitment advertisements.
- Assisted in preparation of clinical trial plans to ensure compliance with regulations.
- Created, maintained, and tracked study files in ETMF according to company SOPs and guidelines.
- Utilized clinical trial management systems (CTMS/Etrack) and EDC tool Medidata Rave effectively.
Johnson & Johnson - CentocorChesterbrook
Clinical Research Associate-Trial Document Services (Cardiovascular, Rheumatology, Oncology)
02.2008 - 09.2008
Job overview
- Managed collection, review, and approval of site regulatory documents for multiple clinical trials, ensuring compliance with all regulations and guidelines.
- Conducted quality control audits of site documents to maintain accuracy and compliance standards.
- Facilitated communication with sites and WWRA to efficiently resolve regulatory document issues.
- Collected data to analyze cycle times of site regulatory documents and recommended process improvements.
GlaxoSmithKlineKing of Prussia
Study Manager (Cardiovascular & Metabolic)
06.2006 - 12.2007
Job overview
- Led operational implementation of clinical studies, ensuring adherence to regulatory standards.
- Coordinated site selection to improve patient recruitment outcomes.
- Audited sites for FDA readiness and verified accuracy of trip reports.
- Utilized clinical trial management systems to analyze data effectively.
- Developed informed consent models and reviewed site-specific forms for clarity.
- Tracked study budgets, reporting expenditures and conducting monthly accruals.
- Processed site invoices efficiently to uphold financial oversight.
Johnson & Johnson – CentocorMalvern
Clinical Research Assistant (Cardiovascular & Rheumatology)
04.2005 - 05.2006
Job overview
- Applied practical knowledge in PDS, Oracle Documentum, and Pharmadoc systems.
- Processed SAE reports from sites for medical monitor sign-off and distributed per company SOPs.
- Established regulatory document review priorities to facilitate IRB/EC submissions in clinical trials.
- Coordinated temperature excursion reports with clinical supplies coordinator for resolution.
Johnson & Johnson – CentocorMalvern
Clinical Trial Document Services Specialist (Cardiovascular & Rheumatology)
07.2003 - 03.2005
Job overview
- Managed collection, review, and approval of site regulatory documents for multiple clinical trials, ensuring compliance with all regulations and guidelines.
- Conducted quality control audits of site documents to maintain accuracy and compliance standards.
- Facilitated communication with sites and WWRA to efficiently resolve regulatory document issues.
- Collected data to analyze cycle times of site regulatory documents and recommended process improvements.
Johnson & Johnson – CentocorMalvern
Regulatory Affairs Associate
01.2003 - 06.2003
Job overview
- Expert review capabilities of R&D reports to assure that the contents and presentation are adequate for submission to health authorities.
- Critical review of documentation from worldwide clinical investigator sites (Site Regulatory Packages) prior to site initiation, to ensure quality and receipt of the regulatory, financial and legal documents.
- Sending out monthly New Investigator Submissions to the FDA.
Wyeth-Ayerst ResearchCollegeville
Data Quality Specialist
05.2002 - 12.2002
Job overview
- Extensive analysis of draft regulatory documents (CSR’s, protocols, Investigator brochures, IND annual reports, etc.) to insure validity and accuracy of safety and efficacy data in all text and tables of these documents before internal sign off and submission to FDA or international regulatory agencies.
- Communicating verbally or in written form to all writers, clinical scientists and bio-statisticians to resolve discrepancies identified by me prior to final document approval.
- Prepared detailed review-results summaries (sometimes quite extensive) and conducted discrepancy resolution with writers to reinforce accuracy of data in all the documents reviewed.
GlaxoSmithKline R&DUpper Providence
Summer Intern, Clinical Data Management
05.2001 - 08.2001
Job overview
- Collaborated with researchers to analyze data and prepare reports.
- Participated in team meetings to discuss project progress and challenges.
- Maintained accurate records of all activities performed throughout internship period.
- Prepared reports summarizing project progress and results for management review.
- Maintained positive working relationship with fellow staff and management.
Biological EvansHyderabad
Trainee
04.1998 - 07.1998
Job overview
- Manufacturing: Participated in validation of new drug candidates. Extensively trained in tablet manufacturing and packaging departments. Gained understanding of various manufacturing processes for various formulations such as capsules, syrups etc.
- Quality Control: Trained in various quality control techniques such as HPLC, IR/UV Spectroscopy and procedures such as dealing with formulation problems.
Education
Massachusetts College of Pharmacy
Master of Science from Pharmaceutics
01-2002
University Overview
GP Reddy College of Pharmacy
Bachelor of Pharmacy
01-1999
University Overview
Winner of Pharmacy quiz in National Pharmacy week, Nov 1998
Skills
- Clinical trial management
- Protocol development
- Risk management
- Global study execution
- Team collaboration
- Patient recruitment
- Effective communication
- Problem solving
- Mentoring peers
- Continuous improvement
- Analytical and critical thinking
- Computer skills
- Calm under pressure
- Regulatory document review
- Performance evaluation
- Communication
- Remote office availability
- Friendly, positive attitude
- Cultural awareness
Affiliations
Affiliations
Life Member Andhra Pradesh State Pharmacy councilAbstracts And Seminars
Abstracts And Seminars
- Development of Formulation and In-vitro evaluation of Pulsatile Drug Delivery system, American Association of Pharmaceutical Scientists, National Conference, Toronto, 11/01/02
- Formulation and In-vitro evaluation of Pulsatile Drug Delivery, 18th Annual Research Forum, Massachusetts College of Pharmacy and Health Sciences, Date not specified
- Pulsatile drug delivery using an impermeable capsule body, Massachusetts College of Pharmacy, 03/01/01
- Development of Multi-functional matrix using an impermeable cylinder, Massachusetts College of Pharmacy, 03/01/00
References
References
Excellent References Available Upon RequestResearch
Research
Massachusetts College of Pharmacy, Boston, MA, 08/01/99, 04/01/02, Accomplished research work entitled 'Formulation and in-vitro evaluation of Pulsatile Drug Delivery system'. This formulation is aimed at delivering the drug after a lag time to cure morning stiffness and pain for rheumatoid arthritic patients (chronopharmacological disorders). The formulation was developed by filling the drug and the excipients in an impermeable polypropylene cylinder (Eppendorf cups with locking caps) and plugging the cylinder by using an erodible tablet/plug made by mixing polymer Methocel, directly compressible Lactose with different concentrations of Avicel. Mixtures of different viscosity grades of Methocel, Lactose and different percentages of Avicel were studied for a desired drug release profile /lag time. Formulated and developed a stable S-Ketoprofen toothpaste.Timeline
Sr. Clinical Trial Manager
Johnson & Johnson-Janssen R&D LLC
01.2012 - Current
Clinical Scientist (Cardiovascular, Metabolic, Oncology)
Bristol Myers Squibb
02.2010 - 12.2011
Global Trial Management Associate (Pulmonary)
Johnson & Johnson - Centocor
10.2008 - 01.2010
Clinical Research Associate-Trial Document Services (Cardiovascular, Rheumatology, Oncology)
Johnson & Johnson - Centocor
02.2008 - 09.2008
Study Manager (Cardiovascular & Metabolic)
GlaxoSmithKline
06.2006 - 12.2007
Clinical Research Assistant (Cardiovascular & Rheumatology)
Johnson & Johnson – Centocor
04.2005 - 05.2006
Clinical Trial Document Services Specialist (Cardiovascular & Rheumatology)
Johnson & Johnson – Centocor
07.2003 - 03.2005
Regulatory Affairs Associate
Johnson & Johnson – Centocor
01.2003 - 06.2003
Data Quality Specialist
Wyeth-Ayerst Research
05.2002 - 12.2002
Summer Intern, Clinical Data Management
GlaxoSmithKline R&D
05.2001 - 08.2001
Trainee
Biological Evans
04.1998 - 07.1998
Massachusetts College of Pharmacy
Master of Science from Pharmaceutics
GP Reddy College of Pharmacy
Bachelor of Pharmacy