Clinical data manager job description

Responsibilities

As the Data Manager, you will participate in all research activities as part of the clinical research team located at UCLA/UCLA Santa Monica while under the direction of the COG Principal Investigator, Lead COG Study Coordinator (team leader), study investigators, Division Chief, and Clinical Research Lead in the Department of Pediatrics. You are responsible for completing the data management of clinical research studies of all clinical research studies specific to the Division of Pediatric Hematology/Oncology. This includes responsibility for collection and transcription of research patient data and study related information into research records (CRFs) and assists with maintenance of regulatory files to fulfill research requirements. You will work with study monitors to process and collect accurate data in a timely manner and assist investigators and study coordinators in clinic settings. You will work flexible hours and/or overtime to meet study deadlines and requirements. Work may be assigned by the Division Chief/PI, Lead Study Coordinator, Regulatory Coordinator, investigator or administration, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner.

Qualifications

Required Skills, knowledge, and abilities:

Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts and record accurately and timely, information into study records and other appropriate research data forms.

Clinical research experience, with in depth knowledge of clinical oncology as it pertains to clinical trials and studies.

Demonstrated knowledge of 'good clinical practices' for clinical research as defined by the FDA.

Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.

Demonstrated knowledge of all components the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, patient care management, etc.

Computer skills using PC platform computers with proficiency in Excel, Word, FileMaker pro to enter data and generate correspondence accurately.

Preferred Skills, knowledge and abilities

Bachelors degree in related field

UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person's unique achievements and experiences to further set us apart.

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
Job Description

As part of the Global Biometrics team, under the responsibility of the Manager of DM & Clinical Programming , our new Senior Clinical Data Manager will be responsible for leading and overseeing all data management activities for in-house and outsourced clinical trials.

Job Responsibilities

Operational leadership of data management tasks for assigned studies from start up to close out (including but not limited to eCRF design & edit checks, UAT, data management plan, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock) Ensure adequate documentation and application of internal and industry standards best practices across studies CROs and Vendors oversight for all DM related activities providing consistent team direction/guidance and monitoring quality of work through key performance metrics Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks Participate in Data Management department infrastructure, by contributing to SOPs/Work Instructions development, CRF standards development and cross-functional process improvement initiatives. Support PM & Contracts on budget related activities Mentoring of junior staff



Minimum Requirements


Minimum 7-10 years of Sr. clinical data management experience in the Pharma/Biotech industry Experienced in leading a clinical study. Statistical Programming experience is a plus. Extensive technical experience using EDC systems (ideally Medidata RAVE) Strong experience in CRO and vendor oversight with consistent track record of on-time quality deliverables In-depth knowledge of DM industry standards, best practices and CDISC implementation (CDASH, ODM, SDTM) Bachelor's degree or higher in the scientific, life sciences or computer sciences field or related discipline Strong and effective oral and written communication skills and interpersonal skills to effectively collaborate in a cross-functional team environment Ability to adapt and manage competing and rapidly changing priorities Fluent English (oral and written)

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!

Key Purpose:


Working independently and in consort with management, the Principal Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on clinical research projects.

The Principal Clinical Data Manager will work on mid-to-large complex projects in various indications, at times serving as program manager, overseeing multiple studies under the same client. S/he will lead a team of CDMs to ensure all the contracted activities are carried out according to the Standard Operating Procedures of Veristat and/or Sponsor specific requirements.

In consort with Data Management leadership, the Principal Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices.

S/he, in consultation with the managers, will assist with the training of other data managers on project specific and general data management processes, procedures and systems, as well as providing training to other functions across the company as needed.


Primary Duties + Responsibility:


Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues. May also serve as support for other Lead Clinical Data Managers as needed. May serve as Program Data Manager for clients with multiple studies - will ensure consistency and efficiency across the board for database design elements, document development, and data trends/discrepancies. Oversees individual leads within the program and may contribute to employee development initiatives as a result. Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure. Develop or quality control review Data Validation Specifications (DVS) documents, program edit checks and other system functions within EDC as needed, and facilitate or participate in User Acceptance Testing (UAT) prior to study go-live. Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans. Responsible for data cleaning activities including data review, query generation and management, and development of study metrics either through direct action or delegation to other team members. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team. Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.). Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation. Perform quality control activities on projects across the department providing feedback to necessary individuals and working with them to correct any issues. Partner with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and will integrate well with the other activities. May lead trainings and/or department initiatives to advance team's understanding of these areas and/or improve related processes; may also serve as an internal representative for Data Management to effectively educate other departments as needed. May serve as a technical lead in a specific area across projects within the department (e.g., Coding Expert). Serve in a Project Management capacity as deemed necessary and appropriate. Provide mentorship and/or training opportunities for junior level staff within the Data Management department. Play an active role in business development activities, such as bid defenses and capabilities presentations as the Data Management Team representative, and/or participate in scoping out DM estimates for new Requests for Proposals. Participate in activities related to inspection-readiness, including representing the Data Management group at audits (internal and external). Lead strategic consulting efforts on behalf of the Data Management team.



Experience & Minimum Requirements:


Bachelor's degree in a related field & 7+ years of relevant experience; at least 5 years' experience in clinical data management experience in a clinical research setting and 4 years of experience in leading project teams, required. Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example, and demonstrated skill for technical leadership of staff. Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes . Demonstrated ability to operate with the "big picture" in mind and serve as a thought partner to management as needed. Expert level skills in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX), with a strong desire and ability to learn new applications. Detailed understanding of project planning and management methods. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Ability to work in different projects with different priorities and act as team mentor, and provide data management expertise.



Additional Requirements:


Driving/Travel requirements - Travel up to 0% - 25% (US, Canada, or International) Physical requirements - ability to occasionally lift/move up to 25 lbs. Hours/Conditions - US: 40 hour work week; Canada & UK: 37.5 hour work week FLSA Classification - Exempt


Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.