Manager - Scientific Affairs / Medical Services

Lambda Therapeutic Research

3-5 years

Preferred by Comapny

Ahmedabad

12 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager - Scientific Affairs / Medical Services

Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.

About Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO) with headquarters in Ahmedabad, India. With a presence in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), London (UK), and Warsaw (Poland), Lambda offers comprehensive clinical research services across the innovator, biotech, and generic pharmaceutical industries.

Lambda has achieved significant milestones, including acquiring Novum Pharmaceutical Research Services in 2019 to expand its North American presence. The company has earned accolades such as the ‘Best Indian CRO’ by Frost & Sullivan, the ‘Regulatory Excellence’ Award at the CPhI Awards 2023, and ‘Industry Partner of the Year’ at the Global Generics & Biosimilar Awards 2023.

These accomplishments reflect Lambda's commitment to regulatory excellence, industry leadership, and impactful collaboration.

Position Overview

The Manager - Scientific Affairs/Medical Services plays a pivotal role in ensuring the scientific and medical integrity of clinical studies. This position involves acting as a medical monitor, collaborating with cross-functional teams, and maintaining compliance with Good Clinical Practices (GCP) and regulatory standards.

Key Responsibilities

Scientific and Clinical Knowledge

Maintain expertise in specific disease areas relevant to assigned studies.
Keep abreast of clinical study documentation, regulatory requirements, and operational procedures.
Conduct eligibility reviews for assigned studies.

Medical Monitoring

Act as the medical monitor for assigned studies, serving as a clinical point of contact for cross-functional teams and stakeholders.
Perform or oversee ongoing medical reviews of study data, including identifying trends, outliers, and protocol violators.
Conduct clinical reviews and address relevant medical inquiries.

Collaboration and Communication

Participate in clinical study team meetings and present updates at department, project, and corporate meetings.
Collaborate with Lead Medical Monitors (Lead-MM) during study setup, conduct, recruitment activities, and reporting.
Assist in site inspections, readiness activities, investigator meetings, and site training as required.

Regulatory and Ethical Compliance

Adhere to ICH/GCP guidelines and demonstrate ethical conduct at all times.
Ensure study data and activities comply with clinical research and regulatory standards.

Allied Responsibilities

Demonstrate knowledge of clinical research methodology, biostatistics, and the drug development process.
Exhibit excellent interpersonal, communication, and influencing skills.
Maintain business acumen in clinical research industry functions and roles.
Deliver professional presentations and leverage Microsoft Office and virtual platforms effectively.

Experience & Skills Required

Experience

0-2 years of experience in clinical research within an academic or industry setting (pharmaceutical, biotech, or CRO).

Educational Qualifications

Bachelor’s degree in clinical medicine is required; advanced degrees such as MD are preferred.

Technical Skills

Proficiency in Microsoft Office (Word, Excel, PowerPoint) and virtual platforms.
Strong analytical and organizational skills to manage complex clinical research processes.

Soft Skills

Effective verbal and written communication skills.
Ability to influence without authority and foster collaboration.
Capability to travel domestically up to 30% of the time.

Competencies

Accountability: Take responsibility for clinical study outcomes.
Communication: Demonstrate clarity and professionalism in interactions.
Leadership: Guide teams with initiative and strategic direction.
Flexibility: Adapt to evolving study requirements and environments.
Planning & Organizing: Prioritize tasks for efficient and effective study execution.

Why Join Lambda?

At Lambda, we are committed to creating a supportive work environment that values excellence, innovation, and collaboration. This role offers an opportunity to contribute to impactful clinical research while advancing your career in a globally recognized organization.

Be part of a team that shapes the future of healthcare through dedication, expertise, and cutting-edge solutions.

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

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 |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

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 |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

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 |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Brazil | Sao paulo |

Attica :

Athens | Koropi |

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 :

Hà Nội | Hanoi |

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 :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

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 |

Welcome Back

Create Account

Manager - Scientific Affairs / Medical Services

Job Description

Job Title: Manager - Scientific Affairs / Medical Services

About Lambda Therapeutic Research Ltd.

Position Overview

Key Responsibilities

Scientific and Clinical Knowledge

Medical Monitoring

Collaboration and Communication

Regulatory and Ethical Compliance

Allied Responsibilities

Experience & Skills Required

Experience

Educational Qualifications

Technical Skills

Soft Skills

Competencies

Why Join Lambda?

Recommended Jobs

Manager, Heor

Manager, Cdm (Fsp)

Associate Manager Safety Data And Pv Systems

Principal Site Grant Manager

Clinical Affairs Manager, In Vitro Diagnostics

Clinical Trial Manager

Fsp Medical Writing Program Manager (Remote; India)

Lead Clinical Data Manager (Remote)

Lead Clinical Data Manager (Remote)

Lead Clinical Data Manager (Remote)

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England