Raghu Thimmiah

Raghu Thimmiah

Clinical Trial Site Operations & Management | Clinical Data Operations & Management | Regulatory Services Operations & Management | Drug & Medical Devices Clinical Development & Research |

Hyderabad, Telangana, India
4K followers 500+ connections

About

Clinical Trial Site Operations & Management | Clinical Data Operations & Management | Regulatory Services Operations & Management | Drug & Medical Devices Clinical Development & Research | Profile:

Classic & ideal Operational Management & Administration professional with 30+ years in clinical trial research & other related experience involving Clinical & Regulatory Operations and Management + Clinical & Regulatory Business Operations + Pharmaceutical Sales, Marketing & Registered Pharmacist.
Managed 750+ clinical trial study projects with expertise across all the clinical trial phases, stages and therapeutic areas.
Demonstrated success in leading and managing multidisciplinary teams of 200+ Clinical Research personnel to deliver high-quality operational efficiency in clinical trial operations & clinical data operations & clinical business operations domain.
Insightful experience in clinical trial study programs delivery management activities including project management, resource estimation & allocation, risk management and quality management.
Sound understanding of the entire life cycle of clinical operations, clinical data management from protocol development to final data analysis, regulatory submissions & archival.
Leveraged leadership & strategic skills, innovation, practicality & fiscally sound methods to support initiatives including - developing data - collection, retrieval, standardization, transition & semi automation. Designed, created & implemented operational excellence & metrics initiatives.
Expansive competence in presales, proposals, RFPs & contracts - business operations for CTs, global regulatory services, investigator fees & site costs budget estimates.
Competently managed clinical operations & business development activities for multiple clinical trial sites. Proven track record in developing and implementing operational processes that improve competence and quality.

Contributions

Activity

Join now to see all activity

Experience

  • Valnizen Healthcare

    Valnizen Healthcare

    1 year 8 months

    • Valnizen Healthcare Graphic

      Chief Operating Officer (COO)

      Valnizen Healthcare

      - Present 5 months

      Mumbai, Maharashtra, India

      Operations & Management of -
      • Clinical Trial Site Operations - Site Management Organisation (SMO) activities
      • Drug & Medical devices clinical development & research
      • Regulatory services
      • Technology services

    • Valnizen Healthcare Graphic

      Clinical Operations & Business Operations - Consultant

      Valnizen Healthcare

      - 1 year 3 months

      Mumbai, Maharashtra, India

      Providing Clinical & Business Operations services as consultant

  • Sipra Surgi-Med Graphic

    Sr. Ops. Mgr & Zonal Sales Manager

    Sipra Surgi-Med

    - 11 months

    Hyderabad, Telangana, India

    Providing Sales and Marketing Business Operations and Operational Management services and consultative support for a restarting Surgical Drapes and Gowns manufacturing organization.

  • Intellitron Research Graphic

    Senior Vice President

    Intellitron Research

    - 10 months

    Hyderabad, Telangana, India

    Clinical & Regulatory Operations & Management for a Start-up CRO

  • Sapthagiri Super Speciality Hospital Graphic

    Business Development & Clinical Operations - Global Head

    Sapthagiri Super Speciality Hospital

    - 6 months

    Bengaluru, Karnataka, India

    Sapthagiri Institute of Medical Science & Research Centre - Sapthagiri Clintrac Pvt. Ltd.,

    • Headed clinical trial research sites & a team of 8+ personnel, handling services across clinical trial phases I - IV, Bioavailability (BA), Bioequivalence (BE), PK (Pharmacokinetic) & PD (Pharmacodynamics) studies.
    • Restarted & revived clinical trial research sites for an organization & achieved a growth of 80+ lakhs within a span of 2 months.
    • Offered and provided Local Ethics Committee…

    Sapthagiri Institute of Medical Science & Research Centre - Sapthagiri Clintrac Pvt. Ltd.,

    • Headed clinical trial research sites & a team of 8+ personnel, handling services across clinical trial phases I - IV, Bioavailability (BA), Bioequivalence (BE), PK (Pharmacokinetic) & PD (Pharmacodynamics) studies.
    • Restarted & revived clinical trial research sites for an organization & achieved a growth of 80+ lakhs within a span of 2 months.
    • Offered and provided Local Ethics Committee services to ~45+ clinical trials for clients from diverse medical fields, to enhance their clinical R&D objectives.
    • Organized & executed activities liaising between Clinical Operations, Principal Investigator & Ethics Committee Members.
    • Created visibility & streamlined reporting structure, by means of intuitive revenue reports & matrix dashboard for executive leadership.

  • Freyr Solutions Graphic

    Senior Manager-Presales

    Freyr Solutions

    - 2 years 10 months

    Hyderabad Area, India

    • Led pre-sales team of 14+ members, which facilitated global regulatory-focused solutions for the life sciences industry, across 40+ countries for 300+ clients.
    • Standardized operational & administrative processes across eight (08) different business units in regulatory services, pre-sales & English language quality control.
    • Have expertise in regulatory services proposal development & review of ~4200+ worth $25k-$50k each, with successful award rate of >35%.
    • Devised standard…

    • Led pre-sales team of 14+ members, which facilitated global regulatory-focused solutions for the life sciences industry, across 40+ countries for 300+ clients.
    • Standardized operational & administrative processes across eight (08) different business units in regulatory services, pre-sales & English language quality control.
    • Have expertise in regulatory services proposal development & review of ~4200+ worth $25k-$50k each, with successful award rate of >35%.
    • Devised standard proposal templates which optimized the approval cycle of proposal creation & development turnaround to <2 days against the standard norm of 5-7 days. Designed & implemented Internal Peer Review Check (IPRC) process, which reduced the re-work by 50% & increased the output to 12 final proposals/day ~$25k each.
    • 100+ RFPs @ 3-5 RFPs/month, worth >$50k each, were developed, reviewed & submitted with successful award rate of 20+%.
    • Improvised & administered comprehensive "Request Gathering Sheet" as prerequisite questionnaire for clients, resulted in 30% reduction in time spent per proposal Established a knowledge management system comprising of - online reusable repository of presales content, new joiner’s handbook, revised SOPs, proposal templates, pricing & discount sheets, contractual documents across WW regions, SOW & Work Order standard templates.

  • Parexel

    Parexel

    7 years 1 month

    • Parexel Graphic

      Global Study Grant Manager - Clinical Business Operations

      Parexel

      - 4 years 2 months

      Hyderabad Area, India

      • Principal Investigator Fees & Site Costs Estimates; Proposals, RFP's
      • Established & channelized the end-to-end operations for “Study Grant Team” in India, which consisted of 12+ members performing study grant investigator & site cost estimates, proposals & contracts development activities.
      • Enhanced & set new benchmark for development & review process of study grant investigator fees & CT site cost estimates, which enabled submission of~150/month estimates, against the initial output…

      • Principal Investigator Fees & Site Costs Estimates; Proposals, RFP's
      • Established & channelized the end-to-end operations for “Study Grant Team” in India, which consisted of 12+ members performing study grant investigator & site cost estimates, proposals & contracts development activities.
      • Enhanced & set new benchmark for development & review process of study grant investigator fees & CT site cost estimates, which enabled submission of~150/month estimates, against the initial output of ~25-30/month, for various TAs, countries, currencies and cost ranges for global requirements.
      • Created visibility for client & leadership team by designing & development of study grant operational metrics & dashboard.
      • Developed a comprehensive training program for new hires and ongoing education of existing staff on current regulations, guidelines and best practices related to clinical trials, ensuring 100% training compliance.
      • Accomplished the transition of study grant team into Investigator Payment Office (IPO) - Global Site Operations, business unit within 45 days.
      • Managed the budget for all clinical operations activities including staffing, supplies and equipment.

    • Parexel Graphic

      Senior Manager - Clinical Data Processing

      Parexel

      - 3 years

      Hyderabad Area, India

      • Led clinical data management & processing team of 145+ members skilled in data operations, processing, validation & technical database programming analysis (UAT). Delivering & achieving FPFV & LPLV, study timelines, study milestones, nearing 100% quality across multiple CTMS, TAs, study programs & study projects.
      • Created online “Business Continuity Plan (BCP)’ and “Incident Management Process & Plan (IMPP),” for the whole clinical data operations, department.

  • Accenture

    Accenture

    7 years

    • Accenture Graphic

      Operations Lead

      Accenture

      - 5 months

      Bengaluru

      • Led IRIS project for 85+ personnel, with the business unit spanning across CRF design & build, clinical data management & EDO operations for global pharmaceutical client.
      • Supported design & implementation of OPEX metrics like SIPOC, HLPM, DPM, dashboards, whiteboards, process & flow charts to evaluate the benefits of continued process improvements.
      • Designing & deployed the Management Operating System (MOS) & Escalation Matrix (EM), which enabled 15% efficiency in the process through…

      • Led IRIS project for 85+ personnel, with the business unit spanning across CRF design & build, clinical data management & EDO operations for global pharmaceutical client.
      • Supported design & implementation of OPEX metrics like SIPOC, HLPM, DPM, dashboards, whiteboards, process & flow charts to evaluate the benefits of continued process improvements.
      • Designing & deployed the Management Operating System (MOS) & Escalation Matrix (EM), which enabled 15% efficiency in the process through value addition & structured approach.

    • Accenture Graphic

      Therapeutic Area Lead

      Accenture

      - 3 years 2 months

      Bengaluru

      • Front ended a team of 125+ Clinical Data - PLs, SMEs, TLs, Validation Sr. Associates across Neuroscience, Clinical Pharmacology, Bone & Tissue Repair and Infectious Disease TAs - across 7 study programs with 45+ study projects.
      • Led the Data Entry (DE), Hyperlinking & Book-Marking (HLBM) teams of 65+ members across all TAs & their transition into data processing & DB programming activities while phasing out paper-based approach & switching to EDC environment.

    • Accenture Graphic

      Team Lead

      Accenture

      - 3 years 7 months

      Bengaluru

      • Led a team of 65+ Senior Clinical Data Validation (Sr.CDV) & CDV members efficiently in Clinical Data Management (CDM) & processing tasks on 3 Study Programs across 15+ clinical study projects in Neuroscience TA.

  • Ind-Swift Limited Graphic

    Regional Sales Manager

    Ind-Swift Limited

    - 1 year

    Bengaluru

    Pharmaceutical Marketing - Karnataka State as Regional Sales Manager

    Role:
    • Managing a team of Field Sales Managers & Medical Representatives
    • Accountable for strategy and sales of the State
    • Inventory control. Forecasting sales and stock requirements
    • Planning and implementation of promotional strategies
    • Recruitment and training of new recruits and promotional activities
    • Recognition of performances and rewarding top performances

    Highlights:
    •…

    Pharmaceutical Marketing - Karnataka State as Regional Sales Manager

    Role:
    • Managing a team of Field Sales Managers & Medical Representatives
    • Accountable for strategy and sales of the State
    • Inventory control. Forecasting sales and stock requirements
    • Planning and implementation of promotional strategies
    • Recruitment and training of new recruits and promotional activities
    • Recognition of performances and rewarding top performances

    Highlights:
    • Achievement of sales target during months of Aug, Sep & Oct-02
    • Successful launch of new products

  • SUN PHARMA Graphic

    Field Sales Manager

    SUN PHARMA

    - 3 years 6 months

    Head Quarter: Hubli, Karnataka

    SOLARES THERAPEUTIC PVT. LTD., (Division of Sun Pharmaceutical Industries Ltd.,)
    Pharmaceutical Marketing in North Karnataka areas

    Role:
    • Managing a team of Medical representatives & Sales Officers
    • Developed & implemented marketing strategy for products
    • Reviewing existing programs to enhance sales company offerings
    • Developed comprehensive hands-on orientation program for new recruits & enhanced skills in communicating technical & non-technical materials to…

    SOLARES THERAPEUTIC PVT. LTD., (Division of Sun Pharmaceutical Industries Ltd.,)
    Pharmaceutical Marketing in North Karnataka areas

    Role:
    • Managing a team of Medical representatives & Sales Officers
    • Developed & implemented marketing strategy for products
    • Reviewing existing programs to enhance sales company offerings
    • Developed comprehensive hands-on orientation program for new recruits & enhanced skills in communicating technical & non-technical materials to audiences, peers & administrations
    • Focusing on launch of new molecules

    Highlights:
    • Achievement of sales target & getting rewarded
    • Successful launch & meeting sales target of new products like Susten, Edegra, Diclosef, Tizaran, Rofact etc
    • Appointment of new stockists & distributors
    • Successful launch of sales campaigns. Institutional specialist. Breakthrough in product availability in major institutions. Successful study symposiums

  • NATCO Pharma  Graphic

    Trainee Field Sales Officer, Field Sales Officer

    NATCO Pharma

    - 9 months

    Bengaluru

    Initially joined as Trainee Field Sales Officer later got promoted post probation period to Field Sales Officer.
    Role:
    • Promotion & Sales of Pharmaceutical products
    • Providing field training to new recruits
    • Improving profitability in areas assigned & Active participation in team sales, promotional & annual meetings

    Highlights:
    • I was promoted to FSM post within 1 year

    Natco Pharma Limited products were taken over by Sun Pharmaceutical Industries during…

    Initially joined as Trainee Field Sales Officer later got promoted post probation period to Field Sales Officer.
    Role:
    • Promotion & Sales of Pharmaceutical products
    • Providing field training to new recruits
    • Improving profitability in areas assigned & Active participation in team sales, promotional & annual meetings

    Highlights:
    • I was promoted to FSM post within 1 year

    Natco Pharma Limited products were taken over by Sun Pharmaceutical Industries during Nov-1998 & got an opportunity to work in Sun Pharmaceutical Industries Ltd., (SPIL)

  • Assistant and Senior Assistant

    Vardhaman Pharmaceutical Distributors

    - 1 year 10 months

    Gandhi Bazaar, Bengaluru

  • Cipla Graphic

    Medical Communicator

    Cipla

    - 3 months

    Bengaluru

    S & S Medimark (Marketing Franchizee for CIPLA) Was trained by CIPLA Marketing Training experts Mr. Ganesh Nair & Mr. Ashok Nair. This was my first Pharmaceutical Marketing job just after completing my Graduation in Pharmacy.
    Presentation & detailing skills
    Covered Bangalore region

  • Registered Pharmacist

    Maruthi Medicals & General Stores and KVS Mahadeshwara Medical & General Stores

    - 3 years 7 months

    Bengaluru-560033 and Bengaluru-560026

  • Pharmacist

    Ram Medical Stores

    - 11 months

    Nagrarathpet, Bengaluru

  • Pharmacist

    Cash Pharmacy

    - 5 months

    St' Marks Road, Bengaluru

  • Pharmacist

    Ram Medical Stores

    - 10 months

    Nagrathpet, Bengaluru

Education

  • Life Sciences Sector Skill Development Council (LSSSDC)

    Post Graduate Advanced Diploma Program in Pharmaceutical Business Analytics (PGAD-PBA) First Class

    -

    Activities and Societies: Life Sciences Sector Skill Development Council (LSSSDC), under the Ministry of Skill Development & Entrepreneurship, Government of India, eSkill courses Program offered is certified by the LSSSDC. I am offered Certificate Program in Clinical Research, Pharmacovigilance & Clinical Data Management by LSSSDC in addition to the Post Graduate Diploma.

    Specialized skills sets in the fast growing field of business analytics with a focus on pharmaceutical industry, where opportunities are growing. Since Pharmaceutical Business Analytics is a career option with long term growth.

  • National Institute of Business Management (NIBM) Global Graphic

    National Institute of Business Management (NIBM) Global

    Master of Business Administration (EMBA) Operational Management (Elective) FIRST Class

  • Bangalore University Graphic

    Bangalore University

    Bachelor of Pharmacy - BPharm Mathematics First Class

    -

  • Bangalore University Graphic

    Bangalore University

    Diploma in Pharmacy (DPharm) Pharmacology, Pharmaceutics, Pharmaceutical Chemistry, Forensic Pharmacy & Ethics subjects

    Activities and Societies: Registered Pharmacist, under Karnataka State Pharmacy Council, incorporated under Pharmacy Act 1948. Recognized by PCI (Pharmacy Council Of INDIA). Privileged under Pharmacy Act No. VIII of 1948 and as Permanent Member # 16417.

Licenses & Certifications

Recommendations received

More activity by Raghu

View Raghu’s full profile

  • See who you know in common
  • Get introduced
  • Contact Raghu directly
Join to view full profile

Other similar profiles

Explore collaborative articles

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Explore More

Add new skills with these courses