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Senior Clinical Data Manager
1 month ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Pharmiweb provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Pharmiweb is transforming drug and device development for partners and patients across the globe.
About the Role
We are seeking a highly skilled Senior Clinical Data Manager to join our Clinical Data Management sponsor dedicated team. As a Senior Clinical Data Manager, you will be responsible for the full cycle of Clinical Data Management queries, from being in full leadership of your own studies and being the main point of contact with the client, to the most hands-on tasks such as creating eCRFs, cleaning data and performing independently set-up to close-outs duties. You will cooperate in a highly collaborative environment with other Clinical Data Managers, Data Coordinators, Statistical Programmers and others.
Key Responsibilities
Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level
Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects
Communicates and negotiates effectively with all other Program level team members. Primary point of contact for Clinical Data Management (CDM)
Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs, (i.e. ensuring consistency across data quality plans.)
Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on company standards, processes, systems and expectations to external partners, internal partners and third-party vendors
Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology
Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery
Requirements
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)
Experience in leading complex oncology clinical trials
Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting
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 teams by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
Demonstrated managerial and interpersonal skills
About Us
Pharmiweb is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Pharmiweb, visit www.pharmiweb.com.
Equal Opportunity Employer
Pharmiweb is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Pharmiweb strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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