Senior Clinical Study Manager

Actalent; Deutschland; Hybrid; EUR 83.000 - 101.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan — Pre‑tax and R

Life Insurance

Short and long‑term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO / Vacation or Sick Leave

Zusammenfassung

Actalent seeks a Senior Clinical Study Manager to oversee end-to-end clinical trials (Phases 1–4) with focus on quality, regulatory alignment, and data integrity. You will lead cross-functional teams, manage CROs/CRAs, and contribute to IND submissions, ensuring timely delivery and strict SOP adherence.

The role requires strong project management, budget oversight, and hands-on experience with EDC systems, in a hybrid Bala Cynwyd, PA setting, with one on-site day per week and opportunities to

Qualifikationen

• 3–5 years of pharma industry and clinical trial management experience.
• Experience with planning, execution and oversight of phase 1–4 trials.
• Vendor management experience including CROs, CRAs, and third-party vendors.
• Strong clinical operations background including site management and monitoring oversight.
• Hands-on clinical trial management and development activities.
• Budget development and management for clinical studies.
• Knowledge of GCP and ICH guidelines.
• Experience with EDC and trial systems.

Aufgaben

• Write, review, and refine protocols and related documents (amendments, ICFs, operational plans).
• Ensure regulatory compliance for phase 1–4 trials and SOP adherence.
• Contribute to INDs and other regulatory submissions with clinical operations input.
• Oversee CROs, CRAs, and vendors to ensure on-time, quality delivery.
• Participate in CRO selection and evaluation of proposals.
• Develop, manage, and track trial budgets and forecasts.
• Collaborate with internal and external teams to align projects with program strategy.
• Review and approve trial documents to ensure consistency and quality.
• Maintain data integrity and compliance with GCP/ICH and SOPs.
• Oversee site start-up, monitoring, and close-out activities.
• Coordinate patient enrollment, data collection, and safety reporting.
• Provide leadership to cross-functional study teams.
• Monitor vendor performance and implement CAPAs.
• Utilize EDC and trial tech to support operations.
• Maintain relationships with sites and investigators.

Kenntnisse

Clinical trial mgmt

Vendor management

Budget management

GCP/ICH compliance

EDC systems

Site management

Regulatory submissions

Cross-functional leadership

MS Office

Ausbildung

Bachelor’s degree

Tools

EDC systems

MS Office

Jobbeschreibung

Job Title: Senior Clinical Study Manager

Job Description

The Clinical Study Manager oversees end-to-end clinical trial activities across phases 1 through 4, ensuring high-quality execution, regulatory compliance, and alignment with overall clinical and regulatory strategy. This role involves leading cross-functional teams, managing external partners, and contributing to key regulatory submissions while maintaining data integrity and adherence to GCP/ICH guidelines.

Responsibilities

• Write, review, and refine clinical study protocols and related documents, including amendments, informed consent forms, and operational plans.
• Ensure regulatory compliance for phase 1–4 clinical trial activities, aligning all study processes with applicable regulations and guidelines.
• Contribute to the development of Investigational New Drug (IND) applications and other regulatory submissions by providing clinical operations input and documentation.
• Oversee contract research organizations (CROs), clinical research associates (CRAs), and third-party vendors to ensure delivery of high-quality work on time and within scope.
• Participate in CRO selection, including evaluation of proposals, capabilities, and performance metrics.
• Develop, manage, and track clinical study budgets, including forecasting, cost control, and variance analysis.
• Collaborate with internal and external teams to ensure clinical projects align with overall program and company strategy.
• Review and approve clinical study documents, including monitoring plans, site manuals, and other trial-related materials, to ensure consistency and quality.
• Ensure data integrity and compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and internal standard operating procedures (SOPs).
• Oversee site management activities, including site start-up, monitoring, and close-out, to ensure adherence to protocol and timelines.
• Coordinate and support clinical trial operations, including patient enrollment, data collection, and safety reporting.
• Provide leadership to cross-functional study teams, fostering effective communication and collaboration among clinical, regulatory, data management, and other stakeholders.
• Monitor vendor performance, identify issues or risks, and implement corrective and preventive actions as needed.
• Utilize electronic data capture (EDC) systems and other clinical trial technologies to support efficient study conduct and data management.
• Maintain strong relationships with study sites and principal investigators, serving as a key point of contact for operational and procedural questions.

Essential Skills

• 3–5 years of experience in the pharmaceutical industry and clinical trial management.
• Proven clinical project management experience, including planning, execution, and oversight of phase 1–4 clinical studies.
• Demonstrated experience in vendor management, including oversight of CROs, CRAs, and third-party vendors.
• Strong clinical operations background, including site management, monitoring oversight, and adherence to SOPs.
• Hands‑on experience with clinical trial management and clinical development activities.
• Proficiency in budget development and budget management for clinical studies.
• Solid understanding and practical application of Good Clinical Practice (GCP) and ICH guidelines.
• Experience with electronic data capture (EDC) and other clinical trial systems.
• Bachelor’s degree required.
• Proficiency in MS Office and other relevant software tools.
• Strong interpersonal skills with the ability to create and maintain productive relationships with study sites and principal investigators.
• Ability to lead and collaborate with cross‑functional teams in a fast‑paced clinical development environment.

Additional Skills & Qualifications

• Knowledge of neurological or rare disease drug development, particularly in ataxia, is preferred but not mandatory.
• Experience contributing to IND development and other regulatory submissions.
• Familiarity with regulatory requirements for early‑ and late‑phase clinical trials.
• Experience reviewing and approving clinical study documents and operational plans.
• Strong organizational and time‑management skills, with the ability to manage multiple studies or projects concurrently.
• Excellent written and verbal communication skills for clear documentation and stakeholder communication.
• Ability to identify operational risks and issues and implement effective mitigation strategies.
• Motivation to contribute to the development of treatments for rare diseases and to work on programs supported by innovative regulatory initiatives.

Work Environment

This role follows a hybrid model with one day on-site per week in an office located in Pennsylvania, with the option for additional on-site days as needed. The position involves regular collaboration with internal teams and external partners, including CROs, CRAs, and clinical sites, using MS Office, electronic data capture (EDC) systems, and other clinical trial technologies. The environment supports ongoing research and development efforts in rare diseases and emphasizes regulatory engagement and structured clinical operations. The work setting is professional, office‑based, and focused on high‑quality, compliant execution of clinical trials.

Job Type & Location

This is a Contract position based out of Bala Cynwyd, PA.

Pay and Benefits

The pay range for this position is $70.00 - $85.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

If eligible, the benefitsavailable for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Bala Cynwyd,PA.

Application Deadline

This position is anticipated to close on Sep 8, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

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