Planet Pharma · 7 hours ago
Sr. Clinical Data Manager & SAS Programmer
United States
Contract
Remote
Senior Level
5+ years expPlanet Pharma is an established biotech company seeking a senior level Clinical Data Manager skilled in SAS Programming. The role involves overseeing the data management process for clinical trials, including project documentation, data review, and coordination with junior staff and CROs.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Brad Phelps
Responsibilities
The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials
The Sr. CDM has a broad, fundamental knowledge of the data management process and can plan, manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance
Provide SAS Programming assistance
This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the Sr/CDM are delineated below
Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate
Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols)
Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems
Provides oversight of database set-up/migrations/updates including coordinating and performing UAT
Leads the development of internal Data Review Plan and coordinates cross functional team data listing review
Coordinates the internal medical coding review
Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC
Performs external data reconciliation against EDC
Performs Serious AE reconciliation according to SOPs and guidelines, as applicable
Executes and/or distributes data management metrics, listings, and reports
Provides oversight of data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts
Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications
Provides training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed
Proactively identifies potential study issues/risks and recommends/implements solutions
Maintains study DM related documents/files for inspection readiness
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies)
Participates in CRO/vendor selection process for outsourced activities
Supports budget and resource planning across assigned projects
Participates in the development, review and implementation of departmental SOPs, templates, and processes
Participates in department or cross-functional initiatives (as needed)
Contributes to a professional working environment through exemplifying RevMed Core Values
Qualification
Required
Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field
At least three years for CDM and five years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement
SAS Programming experience
Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
Good working knowledge of ICH, FDA, and GCP regulations and guidelines
Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
Knowledge of industry standards (CDISC, SDTM, CDASH)
Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
Ability to handle multiple projects and prioritize effectively, well organized and detail oriented
Proven ability to work both independently and in a team setting
Preferred
CRO/Service provider management experience
Prior oncology/solid tumor experience highly desired
Working knowledge of statistical programming packages (e.g. SAS) is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase