Senior Manager, Data Management - Waltham, United States - Apellis

Description

Job Description

Position Summary:

The Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program. They provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout. They will be responsible for the oversight and management of clinical data management activities outsourced to CROs. The Senior Manager, Data Management will also contribute to the Apellis data management operational improvement efforts to identify, develop, and implement departmental standards, applications, processes, and training.

Key Responsibilities Include:

• Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to scope of work and service agreements.
• Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners.
• Responsible for CRO adherence to project timelines, from study startup through study closeout, ensuring high quality and integrity of all deliverables.
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements.
• Management of external data vendors (non-EDC data) including the coordination of data transfers, header reconciliation, and data cleaning.
• Manage the Cross-functional Data Review process for all assigned studies.
• Review data via listings and visualization tools to report on performance and quality; review will be performed with clinical data within studies and across multiple studies for trend analysis.
• Contribute to the development, review and implementation of Clinical Data Management processes, policies and SOPs.
• Participate in vendor qualifications and audits.
• Oversee the planning, execution, and maintenance of major projects and initiatives, if required.
• Lead data management study inspection readiness activities and the support of submission activities as needed.
• Train and mentor DM staff or members of the clinical trial team on processes, projects, systems, and programs.
• Perform and lead hands-on data management responsibilities for in-house clinical trials.

Education, Registration & Certification:

• Bachelor's degree in a science-related discipline.

Experience:

• 8+ years working in clinical data management at a sponsor organization with experience across multiple indications and EDC platforms.

Skills, Knowledge & Abilities:

• Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs.
• Experience leading a team of CRO data managers to ensure the timely provision of DM deliverables.
• Advanced hands-on knowledge of data management processes and EDC systems.
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).
• Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, identifying and implementing improvements. Able to review, interpret and evaluate clinical data.
• Experience managing and working with multiple types of external data sources.
• Experience with data visualization, analytics, and reporting tools such as elluminate, JMP Clinical, or Spotfire.
• Strong project management skills, and ability to effectively lead and collaborate with various business functions.
• Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects.
• Experience developing initiatives designed to promote efficiency and productivity for data management operations.
• Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
• Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
• Self-motivated, reliable team member.
• CDASH experience.
• Demonstrated ability to influence without authority.
• Solid understanding of clinical drug development processes.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more Visit to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.