Clinical Trial Manager

Biogenesis

5-7 years

$119,000-160,000

South San Francisco

10 April 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

Clinical Trial Manager

Employer: Biogen
Location: South San Francisco, CA
Job Type: Full-time

About Biogen

Biogen’s West Coast Hub in South San Francisco is dedicated to developing targeted therapies for severe immune-mediated diseases. The company prioritizes scientific excellence, innovation, and patient impact through rapid drug development.

Job Description

Role Overview

The Clinical Trial Manager is responsible for designing and overseeing clinical trial operations, including protocol development, operational strategy, and execution. This role involves close collaboration with CRO partners and cross-functional teams to ensure high-quality clinical research. The position is hybrid and requires regular travel to the South San Francisco office.

Key Responsibilities

Clinical Trial Oversight

Develop and implement the study-level operational strategy to ensure efficient clinical trial execution.
Chair or co-chair Clinical Study Team (CST) meetings, providing guidance on study design and execution.
Manage CRO partnerships, ensuring high-quality execution in line with budgets and timelines.
Provide operational guidance to clinical trial sites and key suppliers.
Oversee regulatory documentation (eTMF) and study startup (e.g., site feasibility, selection, and regulatory packet distribution).
Monitor clinical study systems (IRT, EDC) and participate in system testing.
Ensure risk mitigation strategies are in place for study execution.

Regulatory & Compliance

Ensure Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and regulatory compliance in all trial phases.
Support regulatory inspections and adherence to clinical development protocols.
Develop operational plans to support clinical trial execution under Global Clinical Operations (GCO) outsourcing models.

Financial & Resource Management

Oversee and manage clinical trial budgets, including invoice approvals and accrual processes.
Track trial costs, vendor contracts, and financial forecasting to ensure efficiency.
Work closely with CROs and vendors to optimize clinical trial execution.

Who You Are

A strategic and analytical thinker with a passion for clinical research and drug development.
Strong decision-making and leadership skills, capable of mentoring teams and driving operational success.
Adaptable to global clinical trial management, with a commitment to quality, efficiency, and compliance.

Qualifications

Required Skills & Experience

Bachelor’s degree in a scientific discipline with 7+ years of experience in life sciences.
5+ years of experience in clinical trial management overseeing outsourced trials.
Strong project management, risk assessment, and contingency planning skills.
Deep understanding of clinical development, including Phase I-IV trials.
Expertise in GCP, ICH guidelines, and regulatory requirements.
Experience in operational planning and CRO/vendor management.

Preferred Qualifications

Sponsor and/or CRO experience in global clinical trial management.
Investigator site and/or monitoring experience.

Compensation & Benefits

Base salary: $119,000 - $160,000 (based on skills, experience, and location).
Annual cash bonus and equity incentives.
Medical, Dental, Vision, & Life Insurance.
Fitness & Wellness Programs (including reimbursement).
Short- and Long-Term Disability Insurance.
Paid time off (vacation, holidays, sick leave, and parental leave).
401(k) program with company-matched contributions.
Tuition reimbursement (up to $10,000 per year).
Employee stock purchase plan.
Diversity & Inclusion (DE&I) programs and Employee Resource Groups (ERGs).

Why Join Biogen?

Be part of a leading biotechnology company driving cutting-edge research.
Work in an innovative and mission-driven environment.
Collaborate with top-tier talent in clinical research.
Enjoy career growth, mentorship, and leadership opportunities.

Biogen is an Equal Opportunity Employer and participates in E-Verify in the United States.

Apply Now

Advance your clinical trial management career with Biogen. Apply today!

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 :

Sao paulo | Brazil |

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 :

Tartu | Estonia |

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 :

Saitama | Japan |

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 :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

Midrand | South Africa |

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

Clinical Trial Manager

Job Description

Clinical Trial Manager

About Biogen

Job Description

Role Overview

Key Responsibilities

Clinical Trial Oversight

Regulatory & Compliance

Financial & Resource Management

Who You Are

Qualifications

Required Skills & Experience

Preferred Qualifications

Compensation & Benefits

Why Join Biogen?

Apply Now

Recommended Jobs

Trial Delivery Specialist - Clinical Trial Coordination

Sr Clinical Data Associate