Clinical Trial Transparency Specialist

Biogen

1d•$84,000 - $110,000

About The Position

About This Role The Clinical Trial Transparency (CTT) Specialist supports delivery of CTT activities for assigned studies, helping to manage the compliant disclosure of clinical trial registration and results information on public registries and ensuring meaningful trial information is shared with the public. The CTT Specialist is a contributor for one or more areas of the CTT function such as process, technology, and vendor oversight. The CTT Specialist contributes to improving the quality, efficiency, and overall performance of one or more CTT processes to include areas such as planning activity and compliance tracking, protocol registration, tabulated results, and local country disclosure. The Specialist supports maintenance of standard operating procedures and may assist with training. The CTT Specialist has a basic understanding of business needs and information/data flow to contribute to optimization of technological solutions. In support of vendor oversight, she/he may regularly engage with the supplier(s) to review deliverables, metrics, cycle times, and issues. In support of continuous improvement, she/he may also help to identify opportunities to advance a lean and simple operating model in conjunction with the supplier and other departmental team members. The CTT Specialist helps support departmental projects and potentially cross-functional initiatives working collaboratively to ensure alignment across Clinical Trial Transparency and other departments. What You’ll Do

Requirements

B.A. or B.S. degree.
2-4 years of relevant experience in the pharmaceutical industry or equivalent.
Understands the clinical development life cycle.
Knowledge of the complexity and variability of CTT requirements and the relationship to study communication planning.
Must be able to articulate the dependencies and demonstrate an understanding of these areas and where they intersect.
Experience helping to update processes to identify improvements or address gaps to support a lean and simple process.
Experience working with vendors in an outsourced operating model.
Knowledge of plain language summary documents.
Knowledge of leveraging technology to optimize process.

Nice To Haves

Knowledge of data sharing, patient engagement, health equity, and digital engagement is desirable.

Responsibilities

Contribute to the management of disclosure activities for assigned studies including protocol registration, maintenance and results disclosure by preparing inputs, tracking status, and coordinating with internal and external partners.
Act as a key point of contact for study teams to coordinate and plan disclosure activities and liaison with the vendor.
Contribute to the continuous improvement of CTT processes including standard operating procedure documentation and training which may include registration of protocols, disclosure of study results, and disseminating trial information to study participants and other stakeholders.
Support vendors to ensure disclosure activities for assigned studies are completed on time with high quality.
Support activities related to plain language summary documents.
Work cross-functionally on initiatives to continuously improve the quality, efficiency, and overall performance of Biogen processes.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation