Ssu Project Delivery Lead

Syneos Health

6+ years

Not Disclosed

India

10 Nov. 29, 2024

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

Site Start-Up Project Delivery Lead

Location: Syneos Health, Global

About Syneos Health

Syneos Health is a leading global biopharmaceutical solutions organization committed to accelerating customer success. By leveraging clinical, medical, and commercial insights, we deliver real-world outcomes and help customers navigate modern market realities. Our mission focuses on simplifying and streamlining clinical development, putting both the customer and patient at the center of everything we do. With over 29,000 employees across 110 countries, we are passionate about creating meaningful change in the lives of patients.

"Work Here Matters Everywhere."

Why Syneos Health?

We are dedicated to developing our people through career growth, training, mentorship, and peer recognition. Our Total Self culture fosters an environment where employees can bring their authentic selves to work. Syneos Health thrives on diversity and inclusion, uniting people from different backgrounds to build a stronger, more innovative workforce.

Key Responsibilities

Project Collaboration & Stakeholder Management:
- Work with functional area leads (SSU Country Managers, Project Management, Clinical Management) to identify key issues related to site start-up and regulatory pathways, ensuring the successful enrollment of patients.
- Maintain strong customer relationships, ensuring project deliverables meet client expectations and timelines. Act as a liaison between business leads, project management, and clinical teams to achieve project goals.
- Participate in business development activities, including client presentations and proposal development.
Site Start-Up Oversight:
- Oversee all aspects of site start-up activities, including regulatory submissions, investigator contract negotiations, and essential document collection leading to site activation.
- Manage integrated site start-up timelines, ensuring weekly progress updates are provided and any risks or gaps in timing are addressed proactively.
- Collaborate with internal teams to ensure clinical trial agreements (CTAs) and investigator budgets are negotiated and executed on time.
Regulatory & Compliance Management:
- Prepare and submit core submission documents and clinical trial application dossiers.
- Ensure the timely follow-up of Ethics Committee/Competent Authority queries and objections, escalating issues as necessary.
- Ensure compliance with Standard Operating Procedures (SOPs), sponsor processes, and regulatory requirements for all SSU activities.
Budget & Resource Management:
- Monitor SSU budgets, tracking project milestones and ensuring profitability. Take corrective actions when necessary to keep projects aligned with financial goals.
- Use planning and project management tools to ensure resource allocation is optimized, and out-of-scope work is managed appropriately.
Quality Assurance & Process Improvement:
- Identify best practices and contribute to ongoing process improvements within the SSU department.
- Support the development and update of training materials and SOPs/WIs for the SSU team.
- Maintain a strong focus on quality, ensuring all activities are executed according to the highest standards.

Qualifications

Education & Experience:

Bachelor’s Degree (Higher Degree preferred).
Minimum of 6 years’ experience in the CRO industry, or 3 years in SSU or clinical trial environments.
Proven experience leading at least 5 studies, with at least 2 studies covering more than 10 countries across multiple regions.

Skills & Competencies:

In-depth knowledge of clinical trial processes (Phases II-IV) and ICH GCP guidelines.
Strong understanding of clinical trial start-up processes, project management, and vendor management.
Excellent communication, presentation, and interpersonal skills.
Strong negotiating and problem-solving abilities.
Ability to manage multiple projects in a fast-paced environment while maintaining quality and meeting deadlines.

Why Work with Us?

Career Development: Grow and advance your career in a dynamic, global organization.
Inclusive Culture: Thrive in a diverse and supportive environment that celebrates your unique contributions.
Impactful Work: Play a key role in delivering therapies that have a real-world impact on patients.

Additional Information:

Syneos Health is committed to equal opportunity and diversity. If your experience doesn’t match the job description perfectly, we encourage you to apply, as transferrable skills are valued.

Minimal travel may be required.

Apply Now to be part of a team that is changing lives and driving innovation in clinical development.

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

Ssu Project Delivery Lead

Job Description

Recommended Jobs

Quality Assurance Specialist, Medical Communications

Quality Assurance Advisor, Patient Safety (Ps)

Senior Manager – Quality Assurance

Head – Tpm Quality Assurance (Biosimilars) – India

Associate Quality Assurance – Mqa Downstream

Associate Manufacturing Quality Assurance

Trainee, Quality Assurance

Risk Assurance - Senior Analyst

Quality Assurance Principal Associate

Quality Assurance Specialist