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Clinical Study Startup Manager Jobs in Indiana (NOW HIRING)

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... Management * Accurately complete source documentation during participant visits. * Enter study data ... Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard ...

Substantial clinical study protocol experience, as lead author, required * Experience leading and managing teams while authoring regulatory documents with aggressive timelines * Experience in ...

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Clinical Study Startup Manager information

What are the key skills and qualifications needed to thrive as a Clinical Study Startup Manager, and why are they important?

A Clinical Study Startup Manager requires expertise in clinical research processes, regulatory compliance, and project management, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), regulatory submission platforms, and Good Clinical Practice (GCP) certification is typically expected. Strong organizational, communication, and stakeholder management skills help facilitate collaboration and timely study initiation. These skills ensure smooth, compliant, and efficient study startup, which is critical for the overall success and timelines of clinical trials.

What are some common challenges faced by Clinical Study Startup Managers during the site activation process?

Clinical Study Startup Managers often encounter challenges such as varying regulatory requirements across regions, delays in site contract negotiations, and managing the collection of essential documents from multiple stakeholders. Coordinating with cross-functional teams—including regulatory affairs, legal, and clinical operations—requires strong project management and communication skills to keep timelines on track. Anticipating potential bottlenecks and proactively addressing site-specific concerns are critical for ensuring a smooth and timely study startup.

What is the difference between Clinical Study Startup Manager vs Clinical Research Coordinator?

AspectClinical Study Startup ManagerClinical Research Coordinator
ResponsibilitiesOversees study initiation, site selection, regulatory submissions, and startup activitiesManages participant recruitment, data collection, and day-to-day study operations at sites
Required CredentialsBachelor's degree, clinical research experience, knowledge of regulationsBachelor's degree, clinical research experience, good clinical practice (GCP) training
Work EnvironmentCorporate or sponsor offices, clinical trial sitesClinical trial sites, hospitals, research centers

The Clinical Study Startup Manager focuses on preparing and initiating clinical trials, ensuring regulatory compliance and site readiness. In contrast, the Clinical Research Coordinator handles the daily operations at trial sites, managing participant interactions and data collection. Both roles require similar credentials and work in related environments, but their core responsibilities differ significantly.

What does a Clinical Study Startup Manager do?

A Clinical Study Startup Manager oversees the initial phases of clinical trials, ensuring all regulatory, ethical, and site-specific requirements are met before a study begins. They coordinate activities such as site selection, contract negotiation, budget management, and regulatory submissions. Their goal is to streamline the startup process to minimize delays and ensure compliance with industry standards, facilitating a smooth transition to patient enrollment and study execution.
What are the most commonly searched types of Clinical Study Startup jobs in Indiana? The most popular types of Clinical Study Startup jobs in Indiana are:
What are popular job titles related to Clinical Study Startup Manager jobs in Indiana? For Clinical Study Startup Manager jobs in Indiana, the most frequently searched job titles are:
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Clinical Project Manager - Oncology (Client Dedicated/Remote)

Clinical Project Manager - Oncology (Client Dedicated/Remote)

Syneos Health/ inVentiv Health Commercial LLC

Indianapolis, IN • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Posted 21 days ago


Syneos Health rating

8.1

Company rating: 8.1 out of 10

Based on 22 frontline employees who took The Breakroom Quiz

37th of 86 rated pharmaceutical


Job description

Clinical Project Manager - Oncology (Client Dedicated/Remote)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

CLINICAL PROJECT MANAGER II - ONCOLOGYSponsor Dedicated | Remote - United States

Are you passionate about advancing cancer research and bringing innovative therapies to patients worldwide? We are seeking experienced Clinical Project Managers with strong global oncology clinical trial experience to join a high-performing sponsor-dedicated team supporting a diverse portfolio of oncology studies across multiple indications and phases of development.

This is a fully remote, US-based opportunity where you will play a critical role in the operational leadership and execution of global clinical trials. We are specifically seeking professionals with 3+ years of hands-on Clinical Project Management experience leading global oncology studies and collaborating with cross-functional teams, vendors, and international stakeholders.

WHAT YOU'LL DO

As a Clinical Project Manager II, you will help drive the operational execution and delivery of global oncology clinical trials, ensuring studies are conducted efficiently, compliantly, and according to established timelines.

Key Responsibilities
  • Support and partner with Clinical Study Leads and cross-functional study teams on global oncology trials

  • Lead day-to-day study management activities across study startup, conduct, maintenance, and closeout

  • Manage study timelines, deliverables, risks, and issue resolution

  • Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers

  • Coordinate Clinical Trial Team (CTT) meetings and drive action item follow-up

  • Support study-level planning, forecasting, and operational strategy execution

  • Monitor study performance metrics and proactively identify areas requiring intervention

  • Ensure inspection readiness and compliance with applicable regulations and sponsor requirements

  • Collaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality

  • Contribute to study status reporting and executive-level communications

  • Support achievement of study milestones, enrollment targets, database locks, and study closeout activities

WHAT YOU WILL BRING Required Qualifications
  • Bachelor's degree in a scientific, healthcare, or related field is required

  • 3+ years of Clinical Project Management experience supporting global oncology clinical trials

  • Experience managing studies across multiple countries and regions (North America, Europe, Asia-Pacific, Latin America, or other global regions)

  • Vendor management experience required

  • Strong understanding of clinical trial operations and study lifecycle management

  • Experience supporting Phase I, Phase II, Phase III, and/or Phase IV oncology studies

  • Strong working knowledge of ICH-GCP guidelines and clinical research regulations

  • Proficiency with Microsoft Office Suite

  • Ability to work effectively within global, cross-functional matrix organizations

ONCOLOGY THERAPEUTIC AREA EXPERIENCE

Candidates should have direct clinical trial experience supporting one or more oncology indications:

  • Lung cancer (NSCLC, SCLC)

  • Melanoma

  • Renal cell carcinoma (kidney)

  • Bladder cancer

  • Head & neck squamous cell carcinoma

  • Triple-negative breast cancer

  • Cervical cancer

  • Gastric and gastroesophageal cancers

  • Esophageal cancer

  • Hepatocellular carcinoma (liver)

  • Endometrial cancer

  • Ovarian cancer

  • Colorectal cancer

  • Biliary tract cancer

  • Prostate cancer

  • Urothelial carcinoma

  • Hematologic malignancies (multiple myeloma, lymphoma, leukemia)

  • Antibody-drug conjugates (ADCs)

  • Personalized cancer vaccines

  • KRAS inhibitors

  • T-cell engagers

  • Cell-directed immunotherapies

Candidates should be prepared to discuss the indications supported, study phases, geographic scope, and their specific responsibilities on each program.

PREFERRED QUALIFICATIONS
  • Experience independently leading global oncology studies

  • Experience supporting complex, multi-regional Phase II and Phase III programs

  • Experience with early-phase oncology studies (Phase I/Ib)

  • Experience with immuno-oncology, targeted therapies, cell therapy, or hematologic malignancies

  • Familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms

  • Experience working in sponsor-dedicated or FSP environments

KEY SKILLS & COMPETENCIES
  • Strong project management and organizational skills

  • Excellent communication and stakeholder management abilities

  • Proven ability to manage multiple priorities in a fast-paced environment

  • Strong risk identification and mitigation capabilities

  • Detail-oriented with a focus on quality, compliance, and execution

  • Strong collaboration skills across global teams and functions

  • Ability to influence without direct authority and drive accountability across study teams

CLINICAL PHASE EXPERIENCE

We welcome candidates with experience supporting:

  • Phase I / First-in-Human Studies

  • Phase I/Ib Dose Escalation Studies

  • Phase II Proof-of-Concept Studies

  • Phase II/III Registrational Studies

  • Phase III Global Pivotal Trials

  • Phase IV and Post-Marketing Studies

Experience supporting global, multi-country oncology programs through multiple phases of development is highly preferred.

WHY JOIN US?
  • Work on innovative oncology programs advancing new treatment options for cancer patients worldwide

  • Support cutting-edge therapies across solid tumors, hematologic malignancies, immuno-oncology, and cell and gene therapy

  • Join a collaborative, sponsor-dedicated team focused on operational excellence

  • Enjoy the flexibility of a fully remote US-based role

  • Expand your impact across global clinical development programs and contribute to bringing life-changing therapies to patients

If you are an experienced Oncology Clinical Project Manager with 3+ years of global clinical trial management experience and a passion for advancing cancer research, we would love to hear from you.

Salary Range $120,000-135,000

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health


Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information


Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.


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