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Senior Manager, Clinical Data Management

Day One Biopharmaceuticals

Day One Biopharmaceuticals

Data Science
Sterling, VA, USA · Remote
Posted on Wednesday, July 3, 2024
SENIOR MANAGER, CLINICAL DATA MANAGEMENT
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
POSITION SUMMARY:
The Senior Manager, Clinical Data Management is responsible for oversight and support of data management activities for all phases of Day One Biopharmaceuticals clinical trials. This position works collaboratively with cross-functional team members to meet deliverables and timelines and ensures data are collected, managed, and reported clearly, accurately, and securely.
This position has the potential to be fully remote. Occasional travel will be required for in-person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Study Management and Leadership
· Provides clinical data management support and oversight, within the study team, to align on and drive data collection requirements.
· Takes responsibility for assigned studies in the portfolio.
· Efficiently plans, coordinates, and delivers complete, high-quality and reliable clinical trial data in a timely manner for assigned studies.
· Responsible for end-to-end clinical data management activities and serves as a primary point of DM contact for internal and external study team members.
· Manages CRO, if applicable, for DM activities and deliverables in conjunction with study team. Communicates priorities, project plans, scopes, and required changes with DM CRO.
· Works with third party vendor contacts, data, and performs data reconciliation; responsible for data management deliverables.
· Supervise and oversee vendors that have been contracted to handle data management activities (e.g., DM CROs and EDC vendors) and ensure the data are complete, accurate and delivered within the study team agreed timelines to meet company objectives.
· Escalate / communicate vendor status and performance issues to vendor managers and Senior Management, as needed.
· Enforce data standard conventions and quality expectations for clinical data per defined standards. Knowledge of SDTM requirements and controlled terminology and other submissions requirements are important in this position.
· Authors, reviews, and/or revises, and approves DM-related study plans and documentation including, but not limited to, the Data Management Oversight Plan, Data Review Plan, eCRF Completion Guidelines, Data Transfer Agreements/Specifications, and other study documents to ensure quality and standardization.
· Represent DM on cross-functional study team meetings.
· Ensure DM standards and SOPs / WIs are followed for responsible studies.
· Provide input from Data Management project management perspective to plan and coordinate cross-functional and CRO timelines.
· Perform Sponsor User Acceptance Testing (UAT) for the development and ongoing post-production changes within DM clinical trial systems.
· Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document, data plans, and as requested by the clinical team.
· Participate in reviews of TFL output prior to final database locks, as needed.
· Ensure that all data management documentation have been collected and uploaded to the relevant sections of the working files on the server and the study TMF.
· Report query trends and data/query metrics and oversee suggest any changes, additional training as appropriate.
· Lead or support the DM activities related to inspections and audits.
· Other DM assignments as required.
· Able to travel quarterly during business-critical times
QUALIFICATIONS
· BS/BA degree in related discipline with 5 plus years of relevant Clinical Data Management industry experience; or Advanced degree in related discipline with at least 4+ years of industry experience.
· Solid oncology experience is a must
· Database design and data analytics experience is highly preferred
· Able to work collaboratively on multi-disciplinary study teams and develop productive relationships with external vendors
· Sound knowledge of Clinical Drug Development Process, regulatory and ICH guidelines (e.g. EMEA, FDA) and industry standard practices regarding data management
· Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well-versed in industry trends and emerging technologies supporting data collection
· Good understanding of Clinical Data Management roles and responsibilities
· Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
· Excellent oral and written communication skills
· Communicate effectively with cross-functional teams
· Knowledge of submission requirements (e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application)
· Good understanding of the specific data management problematics encountered in rare diseases/pediatric drug development.
· Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
COMPENSATION AND BENEFITS
The salary range for this position is $170,000 to $180,000. Day One Bio considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.