Lead Clinical Data Manager
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Lead Clinical Data Manager position is responsible for the technical and administrative functions associated with a clinical trial. The primary responsibilities include EDC set-up, study database design, data discrepancy management, data review, project support, and study document management. The position will perform duties in compliance with the protocol, data standards, and SOPs.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lead the design of CRFs, CRF completion guidelines, and data handling conventions
- In close collaboration with the clinical study team, develops logic and/or reviews edit check specifications; programs and validates and/or validates edit checks to facilitate cleaning of clinical data.
- Responsible for database design, programming and validation, and maintenance for clinical study databases with a focus on accurate data collection and compliance with data standards and SOPs.
- Coordinate and perform successful conduct of user acceptance testing with participation of Clinical and Biostatistics team
- Assist in the creation, review, and oversight of document such as Data Management Plans, eCRF completion guidelines, and source documents for completeness and consistency
- Manage of external data specifications (such as laboratory or EKG data specifications) in consultation with Clinical Operations and Statistical Programming.
- Lead review of EDC data for completeness and correctness, querying of sites for problems, issues, or trends and escalation within Clinical Development as necessary. Reconciliation of external data (such as laboratory data, serious adverse events/events of interest information, or, if needed, independent review by medical personnel) with EDC data
- Perform basic medical coding activities and liaise with Medical Monitor for coding approval. Collaborate with Pharmacovigilance department to perform serious adverse events reconciliation.
- Interact with clinical study team members to resolve database issues and report on the progress of CDM activities. Represent data management on clinical study teams.
- Use and develop data views for optimal and efficient review of large quantities of data.
- Leads regular data review activities with the clinical team to ensure accuracy, consistency and reliability of data; may oversee personnel performing data entry, data reconciliation, and data discrepancy resolution tasks.
- Perform study close out activities working with internal team and/or CRO per project timeline. Ensure data management documentation is appropriated filed in the electronic trial master files
- Provides database expertise through attendance at meetings and membership on various committees and teams, as required.
- Participate in the development of SOPs and policies to ensure that databases are maintained in compliance with regulations.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s degree in statistics, mathematics, computer science, biology or related scientific field. Master's preferred.
- At least 6 years of relevant data management experience in a pharmaceutical, biotech, CRO or other clinical research setting. CCDM certification preferred.
- 2-3 Yrs as study Lead Data Manager
- Experience managing clinical study data using EDC systems; familiar with multiple phases of clinical development. Prior database development experience.
- Demonstrated ability in developing study documents, particularly CRFs, edit check specifications, and DMPs
- Sound background in CDM tasks and documentation in preparation for study close-out, regulatory submissions, and possible health authority audits.
- Experience with IXRS, ePRO/eDiary, medical coding, and SAE reconciliation preferred.
- Working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
- Hands-on experience and in-depth knowledge in CDISC standards, including CDASH, SDTM controlled terminologies, aCRF, cSDRG, and define.
- Ability to work independently, self-directed, as well as collaboratively in a team
- Excellent organizational, written, verbal, and interpersonal communication skills with great attention to details and ability to multitask. Demonstrated ability to communicate with non-data focused people.
- Ability to work proactively and effectively in a fast paced, high change environment.
- Excellent computer skills and proficient in the used of Adobe Acrobat and Microsoft Office products.
- Experience with CRO and/or vendor management a plus.
- Experience with additional statistical software such as SAS, R and JMP is a plus.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.