Surya Prakash Singh
Hyderabad
Summary
Results-driven Manager with a proven ability to drive business growth and enhance operational efficiency. Utilises strategic thinking and leadership to inspire teams and achieve organisational goals. Builds strong stakeholder relationships and fosters collaboration, delivering transformative results through continuous improvement initiatives.
Overview
3
3
Languages
1
1
Certification
13
13
years of professional experience
Work History
Global Trial Acceleration Manager
Bristol Myers Squibb
04.2024 - Current
- Lead and execute centralized activities supporting global clinical trials, with a strong focus on clinical documentation management.
- Act as a key interface with clinical study sites, Central IRB/IECs, CROs/vendors, Country Trial Managers (CTMs), Clinical Trial Monitors (CTMos), study teams, and cross-functional partners within BMS.
- Provide end-to-end support to study teams during study start-up, maintenance, and close-out phases.
- Served as primary contact for essential document (ED) management, strengthening collaborative relationships with investigative sites to ensure timely document flow.
- Support outsourcing activities by coordinating with operational teams, support groups, and service providers to enable effective selection, contracting, and execution of outsourced studies.
- Ensure compliance with global regulatory requirements, ethical standards, and BMS outsourcing and procurement policies.
- Initiate and manage global study start-up documentation activities.
- Oversee the generation, processing, tracking, and distribution of Confidential Disclosure Agreements (CDAs).
- Contribute to feasibility questionnaire development, distribution, tracking, and consolidated feedback to Global Trial Managers (GTMs), CTMs, study teams, and BIA as applicable.
- Submit potential investigator information to CTSS for debarment review and decision tracking.
- Review essential regulatory documentation and partner with sites to resolve outstanding issues.
- Perform final review of applicable documents, complete site activation checklists, and submit documentation to Regulatory authorities.
- Support or lead site activation activities in compliance with study procedures and regional requirements.
- Provided quality control oversight for study start-up activities, ensuring compliance with regulatory requirements and supporting successful site activation.
- Update and review clinical trial systems (e.g., CTMS, eTMF, vendor systems) to track and report document status for insourced studies.
- Coordinated certified translations of study-level documents (e.g., ICFs, protocols, IBs) to facilitate clear communication and understanding across diverse study sites.
- Assist with preparation and coordination of study-specific materials, including pharmacy files and Investigator Site Files, to support site initiation visits.
- Served as the primary liaison for all centralized start-up activities, ensuring clear communication and coordination among all stakeholders.
- Coordinated the tracking and submission of essential documentation to regulatory authorities.
Sr. Study Startup Associate
Emmes Biopharma UK Limited
07.2021 - Current
- Use MS project to establish study start up timelines and processes for each country
- Work with team members on preparation of regulatory submission packages (e.g., Competent Authority, central and local EC submissions)
- Review site regulatory documents and perform regulatory co-ordination Internationally, by working with the regulatory specialists in the specific countries
- Negotiated investigator contracts with sponsor and sites to ensure alignment on wording and budgets
- Assist with translations co-ordination, e.g. for contracts across EU etc.
- Interact with sponsor to secure authorization of regulatory documents
- Tracked and informed team members on completion of regulatory and contractual documents for individual sites
- Essential document package review for site activation
- Interact with Clinical Operations, Study Team Leader or site on project specific status, communication and deliverables
- Assisted PM in resolving site issues and determining status for product shipment
- Organize and participate in investigator meetings
- Organize and participate in regular team Teleconferences
- Participate in development/review of study-related documents, including informed consent form template, monitoring plan, template source documents, study manual(s), regulatory binder (Investigator Site File), pharmacy binder and other resource materials
- Conduct feasibility studies, if required and participate in site selection
- Coordinate preparation of training materials for Investigator meeting/ kick-off meeting
- Executed additional tasks to support project needs.
- Developed budgets based on Request for Proposal (RFP’s) and Change Notification Form (CNF’s).
- Mentoring new onboards and SME for UK, US and Canadian submissions.
- Process development and streamlining startup activities per sponsor/country requirements.
- Any other activities or duties, as suggested by Line Manager from time to time as required for the company’s business purpose.
Sr. Study Startup Associate
ICON
Chennai
12.2018 - 07.2021
- Working closely with the study teams to develop per subject cost estimates based on study design and schedule.
- Developed budgets based on Request for Proposal (RFP’s) and Change Notification Form (CNF’s).
- Perform site contract negotiation including of budget and contract amendments
- Resolved escalations regarding site contracts from vendors and investigator sites.
- Prepared Investigator site contracts, negotiated requested changes, coordinated contract review with internal customers, and collaborated with Legal department to finalise contracts.
- Interacted with internal customers and prioritised assignments.
- Updated tracking system with site contract data in an electronic library
- Liaised with internal ICON and external stakeholders (e.g. site personnel, IRBs) to provide maintenance support activities throughout clinical trial.
- Prepared, coordinated review, submitted and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorisations and approvals.
- Gathered essential documents necessary for maintenance activities.
- Assisted with finalisation and approval of country and site-specific SIS/ICFs in collaboration with LIC team.
- Lead activities/ tasks & complete the deliverables within timelines, as needed.
- Uploaded final documents to electronic filing systems.
- Primary contact for CTMs, PMs and sponsor for all aspects related to start-up.
Remote Central Monitor
IQVIA
Mumbai
05.2017 - 10.2018
- Performed complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines.
- Ensured accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
- Participated in document management (creation, review, maintenance, storage, as applicable)
- Infosario dashboards data reconciliation with different system.
- Completion and quality check of laboratory normal ranges worksheets follow up with site.
- Confirmed all CRF data is entered, monitored and locked. Resolve/confirm resolution of all queries.
- Preformed Remote Data Review of Infosario Data Analytics, EDC, IVRS, other E-Systems, to review subject data, generate/update queries, per study specific instructions.
- Document review and findings in CTMS, create action items follow up with Site.
- Pre-SIV support: Remote Feasibility support Document Collections and CTMS updates along with system access provision Support in IP release
- SIV support: Remote Site Readiness checks SIV checklist and completeness of document collection per sponsor requirements IP, Lab and Ancillary shipment checks
- IMV support: Assist CRA and Contact site through Monitoring phase of study with respect to, Site Pack Preparation Lab query resolution Explaining study procedure/process/platform if required Remote subject eligibility checks and PD identification via system Routine Interim eTMF audits
- COV support: Data Base Lock support IP and Lab accountability checks and Closeout eTMF audit
Senior Project Assistant (CTA)
PPD
Bangalore
02.2015 - 05.2017
- Performed file reviews and log outstanding issues in project related tracking tools
- Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner
- Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines
- Overseen the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments
- Posted and distributed CTMS project specific guidance document to project team
- Added project team members, global, country and any project level activity plans to project in CTMS
- Managed the setup of eTMF and project files for efficient project execution
- Upon direction of CTM/PM, finalized the table of content for all study files (Central, Internal, Country, Investigator), developed and distributed filing guidelines to clinical team
- Submitted of documents to Central and Internal files and update in CTMS
- Assisted PM/CTM with the creation of study documents, checklists, and reports.
- Assisted in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc.)
- Global Investigator Service (GIS) / CTMS Support: Provided support to merged duplicate contacts and accounts in CTMS. Provided support to IBI/DPA entry.
Clinical Pharmacist
MGM Hospital
11.2013 - 10.2014
- Monitored, documented, and reported adverse drug reactions using VIGIFLOW to enhance patient safety
- Medication Chart Review
- Checking medication errors
- Identified and reported drug interactions to optimise patient medication regimens
- Adjusted medication dosages based on patient needs.
- Provided patient counselling to ensure understanding of medications and adherence to treatment plans
- Drug information services
Education
Pharm D - Doctor of Pharmacy
Vaagdevi college of Pharmacy
Warangal, TG01-2014
B. Pharm - Bachelor of Pharmacy
Maheshwara Institute of Pharmacy
Hyderabad, TG01-2011
Intermediate - Higher Secondary School
New Vision Junior college
Hyderabad, TG01-2007
SSC - Secondary School Certificate
Kabita Public School
Hyderabad, TG01-2005
Skills
- Google Project Management certification
- CTMS (Clinical Trial Management System)
- Activate (startup milestones tracking and management in various platforms, such as CPMS and VEEVA)
- TMF filing and maintenance (Pfizer, ICO Master, Veeva Vault, Activate, and SharePoint)
- Dashboard Reporting
- Preparing for Sponsor, Third Party, MHRA, and FDA audits
- RCA and CAPA
- Process mapping and streamlining activities
- Clinical trial management
- Cross-functional collaboration
- Vendor management
- Document management
- Regulatory compliance
- Data analysis
- Risk assessment
- Team leadership
- Stakeholder engagement
- Crisis handling
Languages
Hindi
Telugu
English
Certification
Google Project Management, In progress
Custom Section
- TAKEDA: PROTOCOL FEB-XR_201:A PHASE 2, RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FEBUXOSTAT 40 MG XR, 80 MG XR, 40 MG IR AND 80 MG IR IN SUBJECTS WITH GOUT AND MODERATE RENAL IMPAIRMENT.
- TAKEDA: PROTOCOL FEB-XR_301:A PHASE 3, RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FEBUXOSTAT 40 MG XR, 80 MG XR, 40 MG IR AND 80 MG IR IN SUBJECTS WITH GOUT.
- CELLTRION: PROTOCOL CT-P13-3.5: A RANDOMIZED, PARALLEL-GROUP, PHASE I/III STUDY TO EVALUATE EFFICACY, PHARMACOKINETICS AND SAFETY BETWEEN SUBCUTANEOUS CT-P13 AND INTRAVENOUS CT-P13 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS.
- CELLTRION: PROTOCOL CT-P13-3.4: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PHASE 3 STUDY TO DEMONSTRATE NONINFERIORITY IN EFFICACY AND TO ASSESS THE SAFETY OF CT-P13 COMPARED TO REMICADE IN PATIENTS WITH ACTIVE CROHN’S DISEASE.
- R-PHARM: PROTOCOL: CL04041023: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO AND ACTIVE CONTROLLED, MULTICENTER PHASE III STUDY OF THE EFFICACY AND SAFETY OF OLOKIZUMAB IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS INADEQUATELY CONTROLLED BY METHOTREXATE THERAPY.
- R-PHARM: PROTOCOL: CL04041025: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED, MULTICENTER PHASE III STUDY OF THE EFFICACY AND SAFETY OF OLOKIZUMAB IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS INADEQUATELY CONTROLLED BY TUMOR NECROSIS FACTOR ALPHA (TNF-Α) INHIBITOR THERAPY.
- R-PHARM: PROTOCOL: CL04041024: A MULTICENTER OPEN-LABEL PHASE III STUDY OF THE EFFICACY AND SAFETY OF OLOKIZUMAB IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.
- PFIZER: PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS.
- PFIZER: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS.
- PFIZER: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE).
- PFIZER: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER.
- PFIZER: OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS.
- BIOPHYTIS: SAFETY AND EFFICACY OF BIO-101 ORAL ADMINISTRATION TO PATIENTS SUFFERING FROM AGE-RELATED SARCOPENIA, INCLUDING SARCOPENIC OBESITY, AGED ≥65 YEARS AND AT RISK OF MOBILITY DISABILITY (SARA-INT).
- REGENRON: OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS.
- VIELA BIO: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VIB4920 IN SUBJECTS WITH SJÖGREN'S SYNDROME (SS).
- XENCOR: A PHASE 1 MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF XMAB23104 IN SUBJECTS WITH SELECTED ADVANCED SOLID TUMORS.
- IDEAYA BIOSCIENCES: A PHASE 1/2 STUDY OF IDE196 IN PATIENTS WITH SOLID TUMORS HARBORING GNAQ/11 MUTATIONS OR PRKC FUSIONS.
- ASTELLAS: A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND PHASE 3 CLINICAL STUDY TO INVESTIGATE THE LONG-TERM SAFETY OF FEZOLINETANT IN WOMEN SUFFERING FROM VASOMOTOR SYMPTOMS (HOT FLASHES) ASSOCIATED WITH MENOPAUSE.
- RENEO PHARMA LIMITED: A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY.
- RENEO PHARMA LIMITED: AN OPEN LABEL, LONG TERM SAFETY STUDY OF REN001 IN PRIMARY MITOCHONDRIAL MYOPATHY PATIENTS (STRIDE AHEAD).
- ANAVEX LIFE SCIENCES CORP: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SAFETY AND EFFICACY STUDY OF ANAVEX2-73 IN PATIENTS WITH RETT SYNDROME.
- ANAVEX LIFE SCIENCES CORP: A PHASE 2B/3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED 48-WEEK SAFETY AND EFFICACY TRIAL OF ANAVEX2-73 FOR THE TREATMENT OF EARLY ALZHEIMER'S DISEASE.
- ANAVEX LIFE SCIENCES CORP: OPEN LABEL EXTENSION STUDY FOR PATIENTS WITH EARLY ALZHEIMER'S DISEASE (AD) ENROLLED IN STUDY ANAVEX2-73-AD-004.
- ANAVEX LIFE SCIENCES CORP: ANAVEX2-73-RS-003 IS A PHASE 2/3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED SAFETY AND EFFICACY STUDY IN PEDIATRIC PATIENTS WITH RTT.
- LUNDBECK: A MULTI-SITE, OPEN-LABEL, SEQUENTIAL-GROUP, MULTIPLE-ASCENDING-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF LU AG13909 IN PATIENTS WITH CONGENITAL ADRENAL HYPERPLASIA.
Websites, Portfolios and Profiles
https://www.linkedin.com/in/dr-surya-prakash-singh-b8487b42/
Disclaimer
I hereby declare that the details mentioned above are accurate to my best knowledge. All the documents, and professional references will be shared upon request if needed.
Hobbies and interests
- test
Timeline
Global Trial Acceleration Manager
Bristol Myers Squibb
04.2024 - Current
Sr. Study Startup Associate
Emmes Biopharma UK Limited
07.2021 - Current
Sr. Study Startup Associate
ICON
12.2018 - 07.2021
Remote Central Monitor
IQVIA
05.2017 - 10.2018
Senior Project Assistant (CTA)
PPD
02.2015 - 05.2017
Clinical Pharmacist
MGM Hospital
11.2013 - 10.2014
Pharm D - Doctor of Pharmacy
Vaagdevi college of Pharmacy
B. Pharm - Bachelor of Pharmacy
Maheshwara Institute of Pharmacy
Intermediate - Higher Secondary School
New Vision Junior college
SSC - Secondary School Certificate
Kabita Public School