The Company
My client has a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV. We currently have an opening for a Clinical Study Manager based in PA.
Role Summary:
Reporting to the VP of Clinical Operations or designate, the Clinical Study Manager oversees the full breadth of operational activities for assigned Clinical Studies.
Duties and responsibilities will include:
- Manages and coordinates all aspects of assigned trials (from study startup through trial maintenance and closeout to finalization of the clinical study report) to ensure they are conducted in accordance with established protocols, Company standards and ICH/GCP guidelines.
- Oversees all study activities and results taking/recommending corrective action to ensure that all assigned studies are completed on time and on budget.
- Assists in the design and writing of clinical protocols for assigned projects.
- Develops and tracks study budgets and timelines to meet all milestones.
- Tracks and reports on study metrics and keeps abreast of study developments.
- Working with our CTA, ensures study documents are maintained in the electronic Trial Master File
- Liaises well with the Drug Supply Manager ensuring seamless management of study drug
- Identifies and recommends vendors and oversees contracting process to ensure study requirements are met.
- Coordinates CRO and vendor contracting process and manages CRO's and vendors to ensure stated objectives and deliverables are met.
- Assists Regulatory Affairs as necessary for filing and other necessary compliance requirements.
- Collects and reviews clinical data and results and ensures reports and summary data are prepared, disseminated, and filed appropriately.
- Determines information and reporting requirements for assigned studies designing forms and procedures, as necessary.
- Other related duties as assigned.
Requirements:
- BSc in a related Life Sciences Discipline, Master’s degree preferred, with a minimum of 5 years experience in a dedicated hands-on clinical operations role or an equivalent combination of education and experience.
- Flexibility to work onsite and/or virtually
- Must have direct experience overseeing clinical studies in the biotech/pharmaceutical industry preferably in an infectious disease indication.
- Excellent ability to track and organize clinical trials.
- Experience with data analysis, report and protocol writing.
- Outstanding communication skills with ability to act independently and to interact effectively with the project and clinical study teams
- Innovative thinker willing to take measured risks within the bounds of compliance to achieve clinical success
- Embraces process simplification and/or continuous improvement managing any change effectively
- Comfortable managing multiple projects and ability to adapt to changing priorities.
- Excellent knowledge and ability with MS Office software; advanced user level in MS Word, Excel and Power Point.
- Strong understanding of Clinical Development.
- Proven project management skills including budgeting, scheduling, risk management and project tracking.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything