ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically 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:
This position has the potential to be fully remote. Occasional travel will be required for in person meetings. ESSENTIAL DUTIES AND RESPONSIBILITIES: Project Management and Leadership
· Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex product development projects.
· Takes responsibility for more complex studies in the portfolio which may require additional Clinical Data Management expertise.
· Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
· Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members.
· Provides strong quality and project oversight over third party vendor data and data reconciliation; responsible for data management deliverables.
· Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (External Vendor Data (i.e. imaging and lab vendors), Rave Safety Gateway).
· Enforces data standard conventions and quality expectations for clinical data per defined standards. Knowledge of SDTM requirements and controlled terminology and other submissions requirements are essential to this position.
· Authors, reviews/revises and approves DM related study plans including Data Management Plan, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
· Represents DM on cross-functional project teams and various study team meetings.
· Lead or support the DM activities related to inspections and audits.
· Takes a lead from a Data Management project management perspective in order to plan and then coordinate cross-functional and CRO timelines.
· Able to travel quarterly and up to monthly during business-critical times CRO Vendor Oversight
· Assist in CRO Vendor selection identification and selection activities.
· 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.
· Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, Data Management Plans and Data Transfer Specification documents.
· Perform User Acceptance Testing (UAT) on/or Sponsor UAT in the development of DM clinical trial systems.
· Contributes to the company’s long term data generation and management strategy
· Ensure data transfer specifications are in place and review data transfers for consistency with company data standards and SDTM specifications.
· Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
· 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.
· 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.
· Prioritize projects and coordinate data management activities in support of corporate goals and objectives.
· Assess and help address data management resource needs as the trial, projects and pipeline advance, and the company grows.
· Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
· Address the business needs of CDM functional customers.
· Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership. QUALIFICATIONS
· BS/BA degree in related discipline; or, Advanced degree in related discipline; or,
· Certification in assigned area
· At least 8+ years of relevant Clinical Data Management industry experience.
· Able to work collaboratively on multi-disciplinary project 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
· Deep 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 senior management and cross-functional teams
· Solid 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.
· Ideal candidate will have solid oncology experience.
· Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations, 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 $180,000- $190,000. Day One 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.
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.