Clinical Trial Manager
Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.
Responsibilities will include, but are not limited to, the following:
- Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
- Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverables
- Oversees/facilitates country and site feasibility/selection processes
- Develops/oversees subject recruitment/retention strategy and related initiatives
- Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
- Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
- Creates, manages, measures, and reports timelines for milestone deliverables
- Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
- Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
- Strong attention to detail and excellent organization skills
- Strong interpersonal skills and communication skills (both written and oral)
- Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Demonstrates effective time management, multitasking and handles time sensitive demands, incomplete information or unexpected events
- Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools
- BA/BS or equivalent degree in scientific discipline.
- Minimum 7-8 years of clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting
- Experience in interactions with outside vendors, e.g., CROs and other vendors
- Experience in global trials preferred
To apply please send CV and letter of interest to email@example.com