Senior Clinical Data Manager Job Details | Olympus Corporation of the Americas

Olympus•Center Valley, PA

56d•$117,068 - $163,896•Remote

About The Position

As part of the Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely and high-quality data management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure integrity of clinical data, oversees application of industry standards, data review and query management, and is accountable for quality study dataset release and consistency for submission data. This role is responsible for overseeing the planning, execution, and delivery of data management activities for complex or pivotal global clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This position serves as a key liaison between clinical operations, biostatistics, and external vendor and is responsible for leading data management responsibilities for several concurrent clinical trials, utilizing the electronic data capture and management systems. This role manages trials in various stages, from planning, to start-up, conduct, closeout, and archiving. The role assists in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to Siemens standards. This role collaborates with the Biostatistics and Clinical Operations team members, and other functions as applicable.

Requirements

BS degree in a Biomedical Science or comparable field of study.
Bachelor's degree with a minimum of 8 years of global clinical data management experience, or a Master's degree with a minimum of 6 years of experience.
Prior experience in a sponsor, CRO, or medical device company. In-depth knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA.
Strong expertise in implementing and maintaining systems for global trials (e.g., Medidata Rave, Oracle InForm, Veeva).
Proven leadership in managing full-cycle data management activities.
In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP.
Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products).
Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience.
Strong experience in vendor management and system validationAbility to collaborate effectively with the study team, cross-functional team members and external partners.
Excellent verbal and written communication skills and interpersonal skills are required.
Excellent analytical, organizational, and communication skills.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency with clinical data systems and MS Office Suite.
Position may require some travel.
Candidates must be authorized to work in the U.S. Occasional meetings out of normal working hours will be required as this role supports a global team (EMEA, Japan, China, APAC).

Nice To Haves

Experience with CDASH/SDTM standards preferred.
Experience supporting PMA, IDE, or 510(k) submissions preferred.

Responsibilities

Work collaboratively with other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
Focus on study-start up and database amendment implementation.
Study level coordination and hands-on CDM tasks, including clinical data review and reconciliation.
Authors data management plans (DMP), case report forms (CRFs), edit check specifications, and data validation rules.
Manage database design, build, testing, and validation activities with internal teams or CROs/vendors.
Provide oversight of external DM and data vendors to deliver high quality data management for all assigned studies.
Oversee data cleaning activities including query generation/resolution, data reconciliation (e.g., SAE, lab, coding), and data reviews.
Conduct ongoing risk-based data reviews to ensure data quality and identify trends or issues early.
Collaborate with cross-functional teams (Clinical Ops, Safety, Biostatistics, Programming, Regulatory).
Manage timelines and deliverables for database locks (interim and final), ensuring audit readiness.
Coordinate with EDC and other data vendors (e.g., ePRO, IRT, central labs), ensuring seamless integration and data flow.
Represent data management in study team meetings and regulatory audits or inspections.
Ensure completeness, correctness and consistency of clinical data and data structure across projects.
Ensure accurate tracking and reporting of study metrics and timelines.
Proactively drives quality and efficiency to meet timelines and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team(s).
Assist with support of regulatory submission activities for assigned projects.
Communication and escalation of study level issues including processes, timelines, resourcing, performance, etc.
Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements as applicable.
Assist in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
Support development and maintenance of CDM SOPs and training materials.
Mentor and train junior data managers or contractors as needed.
Other duties as assigned.