Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery

Randstad USA; Cambridge (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager to enhance clinical trial data processes. This role involves leading process design, ensuring compliance with quality standards, and collaborating across functions to optimize data delivery. The ideal candidate will have extensive experience in clinical data management and a strong understanding of regulatory requirements. Join a forward-thinking organization that values innovation and teamwork, and play a pivotal role in advancing clinical trial data excellence. If you are passionate about improving processes and delivering high-quality data, this opportunity is perfect for you.

Benefits

Health Insurance

401K Contribution

Incentive and Recognition Program

Qualifications

• 6+ years in pharmaceutical industry or clinical research.
• Experience in clinical data management and regulatory submissions.
• Understanding of clinical trial documents and technologies.

Responsibilities

• Support and lead process design for clinical data management.
• Collaborate with stakeholders to implement effective processes.
• Monitor metrics to ensure process health and performance.

Skills

SOP

CRF

Clinical Data Management

GCP (Good Clinical Practice)

CTMS

EDC (Electronic Data Capture)

ICH Regulations

Education

Bachelor's Degree in Life Sciences

Tools

EDC

IRT

eCOA

CTMS

TMF systems

Job description

job summary:
Sr. Manager, Integrated Clinical Trial Data Process Excellence & Delivery

Contract | Remote | 12 Months

• The Senior Manager, Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) function processes for clinical trial data delivery, study reporting, and inspection readiness. They define processes to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions.
• In partnership with functional stakeholders and with Global Development Compliance, they contribute to and may lead within-function and cross-function process definition, training, and change management activities to successfully deliver the functional operational strategy.

location: Telecommute
job type: Contract
salary: $70.00 - 83.50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Support and may lead process design and governance for any of the following GICTDS functions: Clinical Data Management, Clinical Data Engineering, Clinical Data Standards, Clinical Trial Tools and Technologies, Risk Based Quality Management, Medical Writing, Information Management and Operational Systems, and Emerging Priorities and Innovation.
• Partner with Global Development Compliance (GDC) GCP Process Excellence to develop and implement these processes.
• Serve as functional process lead or business process owner delegate for a defined set of processes. Includes liaising with GDC on continuous process improvement, serving as process expert for end-users, and serving as point of contact for Quality related activities/initiatives.
• Collaborate with key stakeholders such as functional heads, business process owners, and clinical data system owners and product teams to support the implementation and maintenance of effective process(es) across the company Network.
• Contribute to decision making to determine and clarify roles and responsibilities across functions and to determine how process responsibilities will be executed using clinical trial systems and technologies.
• Contribute to development of new processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and company SOPs).
• Monitor metrics and feedback from the global network and users to ensure the health of the process and performance against measures that are aligned with the organization strategies.
• In partnership with GDC GCP Process Excellence, collaborate with both asset teams and leaders within Global Development Operations (GDO) to identify opportunities for improvement in the company's clinical trial data delivery & study reporting processes including optimizing roles and responsibilities cross-functionally.
• Support the company's clinical trial data delivery & study reporting process strategy based on external and internal perspectives to achieve GICTDS short-term and long-term goals.
• Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with GICTDS objectives.

qualifications:
Required

• Bachelor's Degree or international equivalent required; Life Sciences preferred.
• 6 or more years' experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
• 6 or more years of operational experience in clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.
• Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
• Understanding of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Demonstrated matrix leadership and communication skills.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Preferred

• Global/international experience preferred, including the ability to collaborate with team members in other locations.

*LI-AT1


skills: SOP, CRF, Clinical Data Management, GCP (Good Clinical Practice), CTMS, EDC (Electronic Data Capture), ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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

Required

• Bachelor's Degree or international equivalent required; Life Sciences preferred.
• 6 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
• 6 or more years of operational experience in clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.
• Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
• Understanding of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Demonstrated matrix leadership and communication skills.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Preferred

• Global/international experience preferred, including the ability to collaborate with team members in other locations.

*LI-AT1