Covance Clin Data Mgr I in Raleigh, North Carolina
Lead Project Data Manager, FSPpermanent, salariedRemote from anywhere in the U.S. or CanadaGet ahead in your career and make a difference in people’s lives!Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others. If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.
The Lead PDM leads and/or supports the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. May assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. As an SDM, the Senior Clinical Data Manager leads the DM team, which is comprised of several extended study team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. This includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan. May also support research-driven activities, or support the handling of data provided by highly specialized functions (e.g., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of the generated data in regulatory processes.
The Lead PDM may also assume the role of a key driver of medical standards implementation and maintenance at the project level as well as ensuring a consistent standards handling in the project’s studies. This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan. Ensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring/coaching of SDM(s) and overseeing the Data Management team.
CDM EXPERTISE- Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
The Lead PDM is responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects (if applicable), or research activities. S/he is contributing to the development and sharing of best DM practices. These efforts cascade throughout the supported research and drug development value chain.
TASKS- Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices
Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.
Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.
Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.
Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team.
Prepares, tracks and implements standard plans (i.e., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.
Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of important deviations and validity findings, planning and conduct of interim and final Blind Review Meeting, preparation and completion of the final Blind Review Report.
Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers tomonitor data arrival and clean up. Shares data arrival and cleanup status and metrics with the Study Team- As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners.
- As applicable, establishes data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions. This includes but is not limited to the following: support of setting data standards compatible with development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development.
OPERATIONAL DATA MANAGEMENT- Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.
- Identifies and issue queries, incorporate query replies and track query status.
Implementing Strategy- Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR, DS&A, Portfolio & Operations, OSBU.
Ensuring Compliance- Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs.
WORK INTERACTIONS- Represents CDM as the Core Study Team member for internal and outsourced studies, and coordinates the DM Team in any aspect.
Tracks and leads project-level data management activities: manage PDM Teams/Early PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; identifies issues, defines and directs resolution measures; reports progress and escalate issues into management.
Manages cross-functional team memberships and interfaces effectively: closely aligns activities with Statistics function applying the 2-Lead model principles, serves as CDM member of the core Clinical Team or Early Clinical Team (as applicable).
Works closely with clinical and safety experts in the definition, preparation and review of reports that are critical to ensuring the quality, accuracy and completeness of analyses on study safety, medical coding and Pharmacovigilance data.
Establishes and tracks data management activities in co-operation with Pharmacokinetic department and Pharmacometrics department, with internal research functions like Biomarker and Bioinformatics, and with strategic external partners.
Develops robust and productive relationships with internal and external business partners: treats others fairly and with respect; manages conflicts constructively; provides timely and relevant feedback.
Thrive personally and professionally as a Lead Project Data Manager Working at Covance, you can bring your skills to the team and expect comprehensive training so that you can continue to grow in your career. You will serve as the technical leader on all projects and identify and implement solutions for our clients in data management.We also offer a competitive benefits package that takes care of you. This includes medical and dental insurance as well as tuition reimbursement, a 401(k) plan with a generous company match, PTO days along with short and long-term disability and life insurance. Why choose to work at Covance• Make a direct impact in the lives of patients• Become successful in the position with exceptional training• Join a high-energy and team-driven workplace• Open up new opportunities for career growthWhat we’re looking for Lead Data Managers are the most successful at Covance with: • 6+ years of Clinical Data Management experience and at least 5 years of leading studies in a CRO setting. Combination of CRO/Pharma is acceptable. • Bachelor’s degree; additional relevant work experience considered in lieu of degree.• Full Experience including study start up, initiation, close out etc. • Demonstrated skill for technical management of studies with 5+ staff.• Experience with Database Build; eCRF creation; UAT experience. • Demonstrated mentoring/delegation, communication and interpersonal skillsGet to know CovanceAt Covance, we value your unique point of view and bold ideas to advance modern healthcare. Join our team and see how our collaborative work environment along with mentoring, training and career development can help you be successful at work and in your personal life. Together, let’s shape new possibilities for your career and advance healthcare around the world. Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Additional relevant work experience will be considered in lieu of formal qualifications.
Broad knowledge of drug development processes.
Understanding of global clinical development budgets and relationship to productivity targets.
Knowledge of effective clinical data management practices.
Knowledge of time and cost estimate development and pricing strategies.
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
Minimum five (5) years relevant work experience in clinical data management and 5 years of clinical data lead experience in Pharma and or CRO setting
Minimum of 3 years of onoclogy experience required.
Financial management of gross revenues
Excellent oral and written communication and presentation skills.
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Demonstrated managerial and interpersonal skills
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.