Lead – Clinical Research (RWE) Medical Affairs
Location: Mumbai, India
Company: Sun Pharma Laboratories Ltd.
Department: Medical Affairs
Reporting To: General Manager – Medical Affairs, India
Team Size: 4 Direct Reports
Employment Type: Full-Time
Role Summary
The Lead – Clinical Research (Real World Evidence) Medical Affairs is responsible for providing strategic and operational leadership for non-regulatory clinical research programs, including Real-World Evidence (RWE) studies, observational studies, investigator-initiated studies (IIS), registries, patient-reported outcome (PRO) studies, electronic medical record (EMR) studies, and other Medical Affairs-driven research initiatives.
The role oversees end-to-end study planning, execution, CRO management, regulatory compliance, budget oversight, stakeholder engagement, quality management, and team leadership while ensuring adherence to GCP, pharmacovigilance requirements, regulatory guidelines, and organizational standards.
Key Responsibilities
Clinical Research Strategy & Governance
Lead the planning and execution of:
Real World Evidence (RWE) Studies
Observational Studies
Epidemiological Studies
Investigator Initiated Studies (IIS)
Registries
PRO Studies
EMR-Based Research
Cooperative Group Studies
Develop operational strategies to ensure timely study execution.
Align research activities with Medical Affairs objectives and therapeutic area priorities.
Ensure compliance with GCP, applicable regulations, and company SOPs.
Process Management & SOP Governance
Develop, update, and maintain:
Standard Operating Procedures (SOPs)
Work Instructions
Study Management Processes
Operational Guidelines
Implement systems and trackers for monitoring study progress and deliverables.
Drive standardization and continuous improvement of clinical research processes.
Ensure audit-ready documentation and process compliance.
Protocol & Clinical Document Management
Review and oversee development of:
Clinical Study Protocols
Case Report Forms (CRFs)
Informed Consent Documents (ICDs)
Investigator Brochures (IBs)
Clinical Study Reports (CSRs)
Safety Assessment Reports (SARs)
SAE Narratives
Individual Case Safety Reports (ICSRs)
Support protocol defense during Subject Expert Committee (SEC) meetings when required.
Ensure scientific and regulatory adequacy of study documents.
Study Execution & Trial Oversight
Ensure successful execution of Medical Affairs-led clinical studies.
Monitor study progress against timelines, milestones, and budgets.
Develop and implement:
Risk Assessment Plans
Risk Mitigation Strategies
Corrective and Preventive Actions (CAPAs)
Maintain Trial Master Files (TMFs) and study records.
Lead study governance reviews and dashboard reporting.
Investigator Initiated Studies (IIS) Management
Evaluate IIS proposals received from external investigators.
Coordinate scientific and operational review processes.
Facilitate IIS approval workflows with internal review committees.
Monitor study execution and compliance with approved protocols.
Ensure alignment with company IIS policies and procedures.
CRO & Vendor Management
Identify, select, and manage CROs and external vendors.
Conduct periodic vendor assessments and performance evaluations.
Review CRO SOPs, systems, and quality processes.
Manage vendor contracts, budgets, and deliverables.
Ensure compliance with organizational procurement and vendor management policies.
Site & Investigator Management
Conduct:
Site Feasibility Assessments
Investigator Identification
Site Selection Activities
Finalize investigator agreements and confidentiality agreements.
Coordinate study-related contracts and financial agreements.
Build and maintain strong investigator relationships.
Support investigator training and engagement activities.
Regulatory & Ethics Committee Coordination
Coordinate preparation and submission of study documents to:
Ethics Committees (ECs)
Regulatory Authorities
Institutional Review Boards (IRBs)
Collaborate with:
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Medical Affairs Teams
Ensure timely approvals and regulatory compliance throughout study execution.
Clinical Monitoring & Site Management
Oversee:
Site Initiation Visits
Monitoring Visits
Site Close-Out Activities
Ensure:
Source Data Verification (SDV)
Informed Consent Review
CRF Review
Drug Accountability
Adverse Event Monitoring
Identify site performance gaps and implement corrective actions.
Ensure recruitment targets and study milestones are achieved.
Safety & Pharmacovigilance Oversight
Ensure timely reporting of:
Serious Adverse Events (SAEs)
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Safety Notifications
Collaborate with Pharmacovigilance teams for safety oversight.
Train investigators and CROs on company PV procedures.
Ensure compliance with local and global safety reporting requirements.
Data Management & Statistical Coordination
Coordinate with internal and external teams for:
Data Management
Statistical Analysis
Query Resolution
Clinical Reporting
Lead data review activities and resolution of data discrepancies.
Support preparation of statistical analysis reports and study summaries.
Budget & Financial Management
Develop and manage study budgets.
Monitor project financial performance and resource utilization.
Coordinate budget planning with internal and external stakeholders.
Ensure appropriate financial controls and compliance.
Manage trial-related expenditures and account reconciliation activities.
Audit, Inspection & Quality Management
Lead audit and inspection readiness activities.
Support:
Internal Audits
External Audits
Regulatory Inspections
Develop and track CAPAs.
Ensure quality management systems support study compliance.
Maintain complete and accurate study documentation.
Leadership & People Management
Lead, mentor, and develop a team of Clinical Research professionals.
Establish performance objectives and key metrics.
Drive employee engagement and capability development.
Foster collaboration across:
Medical Affairs
Regulatory Affairs
Pharmacovigilance
Clinical Operations
Quality Teams
Build a high-performance and compliant research culture.
Required Qualifications
Education
MD in Pharmacology (Mandatory)
Experience
10–15+ years of experience in:
Clinical Research
Medical Affairs
Real World Evidence (RWE)
Clinical Trial Operations
Investigator Initiated Studies
Experience managing:
Observational Studies
Registries
Non-Interventional Research
CRO Partnerships
Prior team management experience preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Richmond Hill | Australia | Renfrew | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Yavne | Kfar Saba | Tel Aviv | Be'Er Sheva |Remote :
Green Way | Hammond | Minnesota | Hungary | Riga | Leinster | Xzagreb | Nairobi | Remote - Africa | Remote - Middle East | Regulatory Labeling Manager (NA and LATAM Only) | Melbourne | Slovakia | Bishop | French | Lousiana | Ireland | Blue Bell | Lenexa | Belgium | McFarland | Victoria | Perth | Medan | Remote - Europe | Thailand | Faridabad | Milwaukee | Remote - South America (Latin Americal) | Bountiful | Castlebar | Zaragoza | Switzerland | Texas | Tulsa | Springville | Manipal |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Najran | Rabigh | King Abdullah Economic City | Jeddah | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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