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Job Clinical Data Manager Role At Unicon Pharma, Massachusetts – Apply Now
About the job
The CDML is accountable for all Data Management aspects of the assigned compound and indication from initiation till the closure of activities, ensuring that clinical data completeness, accuracy, and consistency meet the quality standards for analysis and reporting to regulatory bodies, compliant with the local and global regulations.
The CDML function may include Line Management responsibilities of a team of Clinical Data Managers (CDM).
Dependent on the program (phase and number of clinical trials) and the Line Management responsibilities, the CDML may also act as CDM for one or more selected trials (see template Job Description CDM if applicable).
- REPORTING LINE
- ROLES AND RESPONSIBILITIES
The CDML will:
- Take a leadership role with the CRO and other internal and external partners to establish, align and conform Data Management expectations for the assigned compound and/or indication.
- Take a leadership role for Data Management in the Clinical Team, which is ultimately responsible to define the clinical development strategy supporting the Target Product Profile (TPP) across the lifecycle of a compound, starting with the preparation of the “First-in-Human” (FiH) clinical trial throughout “Registration” and post-approval clinical development activities.
- Participate in the creation and maintenance of the Clinical Development Plan (CDP) which is describing the clinical development strategy, comprising effective where possible innovative trial designs.
- Oversee risk identification and risk mitigation strategies for the CDP. Identify risks or deviations from plans and communicate to the Head of Data Management; to the responsible Program Leader (PL) and Management as appropriate, proactively provide solutions and oversee implementation.
- Set quality expectations and timelines for Data Management deliverables and will regularly follow up on Data Management milestones. Ensure inspection readiness at all times.
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.
- Set expectations, communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals in line with the OGSM and the cultural pillars.
For the assigned compounds/indication(s) the CDML will:
- Oversee the CRO selection and contract negotiations.
- Support the Head of Data Management in keeping the oversight of the clinical budget for the assigned indication/program, collaborate with the CDMs and Statisticians to make sure the budgets are prepared, reviewed and updated within the forecast timelines as agreed with the PL and finance. Ensure that the trials and assigned clinical activities are executed within the agreed budget. Pro-actively escalate to the PL.
- Contribute to development of the protocol for the sections relevant for Data Management (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions.
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For the assigned trial(s) under the compound/indication, the CDML will:
- Ensure oversight of all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:
- Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)
- Creation of essential documents (DMP, UAT documents)
- Creation of submission ready clinical data package per regulatory agencies requirements.
- Creation of archival package of clinical data per argenx requirements
- Ensure oversight of all activities related to Data Management:
- Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Head of Data Management, CDM, Data Management CRO and Clinical Team as appropriate.
- Ensure consistency between trials on compound/indication level
- Leverages learnings and shares best practices within the indication and department.
The CDML will also participate in activities other than study-related:
- Lead/participate in initiatives on process improvements.
- Participate in regulatory inspections and company audits.
- May include Line Management of CDMs and full on-boarding of new direct reports.
- Ensure that assigned staff is adequately trained and that training is documented.
- Mentor and enable the growth and development of assigned staff.
- Collaborate with Head of Data Management for own goal setting and goal review as well as of the direct reports.
- SKILLS AND COMPETENCIES
- Able to work effectively within a team matrix as well as independently
- Strong communication and interpersonal skills
- Fluent in English (written and spoken)
- Able to motivate and manage team members with the ability to prioritize tasks and organize workload
- Natural Leader with the ability to work independently.
- Strong people management skills, leader and team player.
- EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Bachelor’s degree or Master’s degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Demonstrated experience in Clinical Data Management and in managing CROs and vendors
- Biotech experience is a plus
- Auto-immune and/or orphan disease clinical study background is a plus
- Line management experience is a plus.
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