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
- 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.
Required Skills
- 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.
- Knowledge of data sharing, patient engagement, health equity, and digital engagement is desirable.
Additional Information
The base compensation range for this role is: $84,000.00-$110,000.00Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Originally posted on Himalayas
