CASY-MSCCN Jobs

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

Overview:

The role will serve as the "TMF Archivist" and support trial-specific clinical oversight of the TMF as established within Genmab's procedural documents, GCP-ICH guidelines, and regulatory health expectations during the conduct and closure of the trial. In this position, the employee will also be responsible for supporting TMF inspection readiness activities and acting as an TMF Subject Matter Expert (SME) to our internal and external stakeholders.

Responsibilities

The key accountability of this role is to support eTMF inspection readiness activities and help drive internal and external stakeholders to be eTMF compliant., by:
Serve as the TMF archival SME and responsible party on the process end for the archival of the eTMFs.
Support internal and external project team with trial closure activities e.g., document reconciliation, closing EDL milestones, etc.
Serve as SME and provide guidance for paper TMF documentation and retention.
Develop training materials and procedural documents surrounding the TMF archival process.
Remaining up to date with GCP-ICH guidelines, regulatory standards and TMF industry updates.
Attending internal and external meetings as needed.
Coordinating with CRO partners to ensure eTMF tasks are performed per Genmab standards and agreements.
Assisting with questions from the eTMF Management Mailbox.
Supporting with the approval of study specific TMF Plans and other study specific TMF related documents.
Monitoring KQI/KPI and eTMF dashboards/reports for trends and outstanding eTMF tasks regarding quality, completeness, and timeliness.
Supporting stakeholders with spot checks related questions.
Assisting with the communication of important eTMF updates e.g., Indexing Key updates, major changes in GenDocs eTMF, CRO agreements related to filing in eTMF.
Performing audit trail reviews.
Assisting with and/or performing GenDocs eTMF User Access reviews per SOP.
Coordinating eTMF oversight activities with internal stakeholders.
Supporting in the development of inspection/audit material (slides, storyboards, etc.), participate in eTMF inspection/audits as needed.
During inspections, this role will support document collection and review as needed in addition to the Function Area (FA) SME/representatives.
Supporting with ongoing study-specific inspection readiness activities e.g., confirming CRO actions are completed by performing cross-checks.
Supporting eTMF post inspection/audit action items.
Supporting the development, testing, and training of eTMF AI initiatives.
Participating in cross-functional working groups as needed.


Competencies
Bachelor's degree preferred. Minimum Associate's Degree required.
Fluent English (oral and written).
2 years of experience working in clinical research, eTMF required.
Experience working with an eTMF system.
Experience with archival paper and electronic TMFs.
Understanding of the eTMF structure (CDISC TMF Reference Model) required.
Strong knowledge of process management.
Prior experience working in clinical research trials and understanding of the drug development processes.
Basic understanding of the eTMF structure (CDISC TMF Reference Model).
Previous experience with document creation and document management.
Operational knowledge to be able to perform their role in accordance with ICH-GCP, internal SOPs and guidelines.
Proficiency with MS Office suite (e.g., Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Forms).
Ability to build stakeholder relationships.
Process oriented with a quality mindset.
Strong interpersonal and communication skills in English.
Active listener with basic analytical and documentation skills ensuring attention to detail and the highest level of accuracy.
A team player but also able to work independently.
Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Goal-oriented and committed to contributing to the overall success of Genmab.

The Employee shall also render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.

For US based candidates, the proposed salary band for this position is as follows:

$0.00---$0.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity