Job Summary: Assists with both early- and late-phase feasibilities under the direction of the Vice President of Early Phase Development (CRO's).
Essential Responsibilities and Duties:- Assists the Vice President of Early Phase Development with CRO proposals which include, intake, tracking, and submission by deadline.
- Enters new studies in CRM and oversees updates to records ensuring data accuracy.
- Submits budget requests to the Finance team through CRM.
- Completes feasibility forms for early and late phase studies as needed.
- Collaborates with site personnel and Business Development Directors to obtain the answers for early phase feasibility completion.
- Identifies, investigates and recommends solutions to potential problems that could prevent a site from being awarded a study and work to submit all award-winning feasibilities.
- Tracks and manages the early and/or late phase feasibility process, maintaining storage of submitted documents.
- Obtains periodic updates to site specific data such as therapeutic area expertise, database numbers, and maintains master file of data.
- Compiles metrics from past studies for sites as requested.
- Completes Sponsor and CRO Requests for Information (RFI's) on behalf of our sites.
- Joins weekly BD, Contracting, and Feasibility Team calls.
- May attend standing calls with CRO's to get updates to current pipeline of studies.
- Conducts email campaigns as requested.
- Attends company BD meetings and conferences when needed and requested.
- Attends any training seminars conducted by the Scientific or Management teams to expand knowledge base.
- Assists in call planning and scheduling when requested.
- Posts new studies to the Top Ops review platform and collects feedback from sites.
- Conducts various activities as required to help achieve the Business Development team's sales goals.
- Provides flex assistance to both the early- and late-phase feasibility teams for completion of feasibilities.
- Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:- Must be able to effectively communicate verbally and in writing.
- Bachelor's degree or equivalent experience in related field.
- Analytical skills: The feasibility manager must be able to analyze data and information to identify potential issues and opportunities.
- Excellent Communication skills: The feasibility manager needs to be able to communicate effectively with clients, team members, and management whether by phone, in emails, or in person.
- Problem-solving skills: The feasibility manager will be able to identify problems and develop solutions to address them.
- Attention to detail: The feasibility manager must be detail-oriented and able to identify potential issues before they become major problems.
- Leadership skills: The feasibility manager will be able to delegate work as needed and motivate team members to achieve project goals.
- Organizational skills are essential to be successful in the position.
- Technical knowledge: The feasibility manager must have a strong understanding of the technical aspects needed to fulfill position duties. Regular use of Microsoft Office (Word, Excel, Powerpoint), Teams, Dynamics, CenExel's Enrollment Dashboard, and Sharepoint is necessary.
Working Conditions - Indoor, Office environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- Remote work arrangement.
