Full Job Description
The clinical data manager (CDM) will serve as Aquestive’s in-house clinical data management leader in the design and execution of the organization’s clinical development plans. This individual will be the subject matter expert (SME), and provide a knowledge base of the end-to-end clinical research and data management processes, as well as regulatory and industry rules and guidance (i.e. ICH, GCP) to support the drug development processes through regulatory submissions and approval.
This individual will be responsible for oversight of programming and data management activities with contract research organization (CRO) vendors in support of Phase I – Phase IV clinical trials. The CDM drives accountability at every possible level ensuring CROs are delivering quality data and documentation on time, on budget and to quality standards and SOPs.
The CDM, under minimal supervision, will also provide in-house supportive statistical analysis as required, provide routine status reports/updates, ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards, and will work with team members (internal and external) to resolve issues proactively. The individual will also mentor other team members in the oversight of CROs and contract data management resources.
Primary duties and responsibilities shall include, but are not limited to, the following:
Contribute to the design of clinical development plan and clinical studies:
Lead/Contribute in development of statistical deliverables including statistical analysis plans (SAPs) for individual and integrated safety/efficacy summaries, tables/listings/forms (TLF) shells, statistical validation plan (SVP), dataset specification (Rule Book), data monitoring, and other programs to perform analysis and display study data.
Define content of statistical tables and reports including necessary explanation of data analysis and identifying any programming constraints.
Review deliverable to. ensure study objectives are being met. Evaluate impacts to clinical development plan and business needs as they arise and take decisive action to ensure priorities are maintained and/or adjusted accordingly.
Oversee CRO vendor data management:
Monitor data management, programming, and/or bio-statistical workflow of contracted CRO to maximize efficiency for all clinical trial DM-related deliverables
Lead development of the Data Management Plan (DMP) across programs and maintain throughout program lifecycle to ensure DMP is followed according to study design/requirements.
Collaborate with CRO and lead clinical teams in the generation/review SAPs and TLFs prepared by CRO to ensure quality and compliance with specifications.
Oversee data management-related responsibilities, including trial start-up, case report form (CRF) development, database build, edit checks, periodic reviews, etc.
Review of external (third party) data transfer agreements; consult with CRO to integrate external data into study programming process flow.
Review of SDTM and ADaM dataset specifications/datasets prepared by CRO to ensure conformity to Clinical Data Interchange Standards Consortium (CDISC) implementation guidelines and standards.
Provide/facilitate support as needed, both technical and clinical, to ensure efficient action, collaboration, and resolution of issues.
Participate in vendor audits as required.
Review Data Transfer Agreements (DTAs) between external data vendors and reconcile data transfers from vendor(s) to sponsor.
Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents.
Ensure clinical data within EDC is of high quality to support lock/unlock as appropriate for statistical review, interim review, and or final database lock.
Accountable for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective.
Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
Direct statistical analysis and programming support:
Provide statistical and SAS programming support within Aquestive to assist with analytic needs as they arise, including protocol development and trial design.
Program ad hoc statistical analyses, such as longitudinal modeling, and generate presentations for specialty data review meetings or in response to requests by clinical or pre-clinical groups.
Provide leadership in the improvement of Aquestive data processes/systems/organization including the establishment of department SOPs, and ensure compliance with existing SOPs
Maintain all relevant programming documentation for designs, scripts, and other processes.
B.S. degree in Scientific or related scientific discipline, with a minimum of 5 years as a Data Manager within a Data Management organization (preferred).
CCDM certification preferred.
10 years of experience (preferred) in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH and SAS macro language), and Data Management in a biotech or pharmaceutical company, or in a contract research organization servicing the pharmaceutical industry. Experience developing SAS macros, database retrieval for data review and statistical programming, CDISC standards for programming of derived datasets, and using the SAS Output Delivery System to output TLFs
Experience working in an outsourced data management model. Vendor oversight of Data Management, SAS Programming, and/or Statistical deliverables
Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management
Prior experience filing a BLA or NDA preferred
Demonstrated leadership in a cross-functional team setting
Ability to manage multiple initiatives and shifting priorities within a small company environment
Proven ability to be innovative.
Proven ability to implement GCP guidelines.
Ability to function as a lead team member on clinical trial project teams.
Familiarity with WHODrug and MedDRA coding dictionaries.
Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.
Must maintain a professional demeanor, as well as a pleasant manner and positive “can-do” attitude while developing and maintaining communications in a cooperative and collaborative manner with all levels across functional teams both internally and externally
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
Flexibility to change priorities and be comfortable with the changing deadlines to meet organization needs when required
Must be detail-orientated, with the ability to work on multiple projects with overlapping schedules and priorities
Highly motivated and a self-starter; demonstrated ability to work independently, as well as in a team while exercising discretion; takes initiative to resolve problems
Possess a blend of business and scientific knowledge, and interpersonal skills; effective communication (both orally and in writing) and excellent listening skills; strong customer service orientation
Follows all company safety practices, SOPs and policies
Work Environment and Physical Demands:
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to perform the essential functions of the position
Hearing and speech sufficient to verbally communicate in person and on the telephone constantly
Typical office environment
Occasional travel off-site for team meetings with collaborators, as needed
Location: Warren, NJ
The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Bachelors or better