Manager, Clinical Data Management

About Perceptive

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.

We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.

Are you ready to help change the world?

Apart from job satisfaction, we can offer you:

HEALTH:

- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)

YOURSELF :

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH:

401(k) program, life & accident insurance and disability insurance

About the role

As Manager, Clinical Data Management, you will oversee and work alongside a team of end-to-end data custodians and will play a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. In this role, you will create data management standard operating procedures and help define overall process and training for Clinical Data Management staff in accordance with SCDM best practices and applicable regulatory requirements. This is a working manager position requiring strong managerial and interpersonal skills alongside hands-on application of skills.

Key Responsibilities

Leadership and Team Management

• Leads, mentors and develops a clinical data management team through direct line management.
• Provides training on Data Management procedures.
• Provides training and monitors performance to ensure the team are operating at the highest level to design and deploy clinical databases for multiple clinical imaging studies.
• Manages team workload and prioritization for all assigned staff.
• Acts as resource manager for dedicated therapeutic area.
• Sets clear goals, providing regular feedback and fostering a collaborative team environment.
• Conducts one-on-one meetings.
• Mentors and ensures the team adheres to best practices and industry standards and facilitates positive career growth.

Data Management

• Creates study Data Management Plans and deployment roadmaps.
• Oversees and participates in the design of study CRFs and databases utilizing eCRF library.
• Provides guidance as clinical database development subject matter expert.
• Monitors study timelines and communicates risk.
• Acts as sponsor portfolio lead representative.
• Oversees multiple concurrent projects.
• Facilitates study team involvement in database development.
• Utilizes metrics to monitor study health.
• Communicates with sponsors and internal leadership regarding study data processes, endpoints, and overall data management process.

Process Oversight

• Creates and maintains Standard Operating Procedures.
• Provides guidance on Data Management best practices and regulatory considerations.
• Defines new procedures and solutions for novel therapeutics and study endpoints.

Other

• Carries out any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills):

• Excellent demonstrable knowledge of regulatory guidelines and requirements for clinical data management.
• Displays excellent understanding of clinical trial data standards.
• Understanding of clinical trial processes, protocols, and regulatory requirements (e.g., FDA guidelines) related to data management.
• Excellent communication (oral and written) and interpersonal skills, to convey data-related information to technical and non-technical stakeholders (internal and external) including clients and research centres.
• Excellent analytical skills with attention to detail and the ability to identify data discrepancies and trends.
• Ability to manage multiple tasks and prioritize work in a fast-paced and deadline-driven environment, with the ability to raise potential issues with deliverables on time.
• Detail oriented and possess excellent organizational skills.
• Builds and maintains an up-to-date awareness of industry trends, best practices, and emerging technologies in data management for clinical research.
• Ability to work collaboratively within a matrix team environment.
• Ability to effectively motivate and guide team members towards shared goals.
• Natural coach/mentor who leads by example with an approachable demeanour and visible leader skills.
• A self-starter and able to work under own initiative.
• Strong analytical and creative problem-solving skills to identify issues and propose solutions.
• Displays technical project management skills and oversight.
• Ability to manage task creation and tracking via ticketing software.
• Demonstrates meticulous attention to detail, documentation and adherence to study protocols and standard operation procedures (SOPs).

Experience, Education, and Certifications:

• Significant demonstrable practical work experience in a clinical or technical setting.
• Line management experience.
• Demonstrable experience in team settings to achieve goals.
• Demonstrable experience and proficiency with clinical data management systems.
• Experience working with research support or clinical team.
• Proficiency in Microsoft Office Suite (Word, Excel (macros), PowerPoint) and data visualization tools is preferred.

• Bachelor's Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science) or equivalent experience in a related field.

• English: Fluent.

This role is remote. Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.

The annual base salary range for this role is $85,282- $158,380. This range represents the anticipated initial annual salary and will vary depending on several factors.

Come as you are.

We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.