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Perceptive Inc. · 1 month ago

Manager, Clinical Data Management

United States

Full-time

Remote

Mid, Senior Level

$85K/yr - $158K/yr

Perceptive Inc. is dedicated to shaping the future of clinical research and supporting the biopharmaceutical industry. The Manager, Clinical Data Management will oversee a team responsible for ensuring data accuracy and compliance while developing standard operating procedures and providing training in accordance with best practices.

Clinical TrialsHealth CarePharmaceutical

Responsibilities

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

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

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

Carries out any other reasonable duties as requested

Qualification

Clinical data managementRegulatory guidelines knowledgeTeam managementData management systemsAnalytical skillsCoachingMicrosoft Office SuiteCommunication skillsOrganizational skillsProblem-solving skillsMentoringAttention to detail

Required

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)

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

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

English: Fluent

Preferred

Proficiency in Microsoft Office Suite (Word, Excel (macros), PowerPoint) and data visualization tools

Benefits

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

Paid time off policy including holidays and sick time

Internal growth and development programs & trainings

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

Company

Perceptive Inc.

Expanding on their combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing.

Founded in 1996