The Associate Director of Early Development Services is responsible for assisting the Director of Early Development Services with program development, planning, implementation and evaluation of the Early Development Services division of LabConnect. This position may also manage and/or delegate responsibility for the development of clinical trial study projects as well as assigns new clinical trials study management responsibilities to a designated Project Manager. Working closely with the Director and Project Managers, the Associate Director of Early Development Services will direct activities to meet our client’s specification, and ensure quality deliverables are on time and within budget. This position will also serve in the capacity of a Project Manager to direct specific developmental clinical trial study activities.
- Assist with supervision of the Early Development Services Project Management, Data Management, and SampleGISTICSTM Operations groups. (Project Managers, Associate Project Managers, Project Coordinators, and Data Managers and Operations personnel) and their respective clinical trial projects.
- Assist the Director as needed with line of business financials and operations.
- Assist with hiring and assignment of EDS staff to include selection, coaching and development as well as retention.
- Oversee EDS annual goals are managed and tracked with 4DX implementation
- Oversee training completion and compliance within EDS staff
- Oversee additional professional training in accordance with EDS Annual Goals and needs
- Oversee client relationships and programs
- Assist in the planning and execution of next generation EDS tools and services
- Meet with other directors and manager/supervisors to stay informed of changes affecting operations.
- Participates in internal quality assurance unit audits as needed.
- Assist oversight of development and maintenance of all project-related documentation (includes proprietary software, SharePoint and other tools)
- Assist the Director in conducting training and SampleGISTICSTM demos for internal and external stakeholders
- Oversees interfacing with laboratory, customer service, business development, project initiation, internal and external project management, information technology, and data management personnel.
- Assists as needed with project design and development with BDO.
- May assist as needed with the client’s clinical study managers to define early development and/or sample tracking needs during budget creation and/or study set up.
- Act as primary project contact for early development services and issue escalation/resolution
- Assist SampleGISTICSTM Data Management in oversight of Digital Form Creation/Printing/Mapping/Coding/validation of forms for digital pen study set ups.
- Assist SampleGISTICSTM Operations in oversight of QC of digital forms and supply kits containing digital forms.
- Assist SampleGISTICSTM Operations with troubleshooting unsuccessful digital pen installations as needed; oversees timely notification to sites when a successful site set up form has been received.
- Oversees the management of digital pen training sessions for study sites.
- Oversees timely technical support to the clinical sites as needed.
- Oversee development of study set up activities, SOP’s, SOW’s, lab manuals, requisitions, digital pen set up and training.
- Oversee internal/external issue escalation and resolution
- Assist Director in working with project managers to setup tracking or specialty services from collection to analysis, and assist with the relevant data management components.
- Oversee that the samples are being collected as per the visit schedule and agreement, using the appropriate kits, documented accurately, and tracked for appropriate testing and data analysis
- Oversee QC of all protocol related documents before they are released to the client.
- Ensure smooth operations of multiple projects simultaneously on a global basis
- Oversee the communication on project status and deliverables amongst multiple internal departments
- Works with client clinical operational team members to ensure appropriate communication channels are maintained and reporting schedules are followed.
Bachelor's degree from a four-year college or university required (Bachelors in the natural sciences preferred). Six years of project management, clinical, laboratory or related experiencerequired. Or combination of 4 years’ experience with master’s degree. Must be experienced in customer service and possess excellent organization and interpersonal skills. Ability to navigate software and databases is a must. Dynamic leader with proven experience successfully leading a team is required. Clinical Research, Project Management or Central Laboratory experiencerequired. Adaptive to change, and excellent problem-solving and multi-tasking skills is required for success in this position.
Knowledge, Skills and Abilities:
- Solid management skills and business acumen
- Staff motivator
- Proven negotiation and problem resolution skills
- Excellent verbal communication skills
- Maintains confidentiality of client protocols and study data
- Demonstrates fiscal understanding of business needs
- Demonstrates executive presence and strong consultation skills
- Knowledge of clinical trial laboratory services and associated products
To perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications including Word, Excel, and Power Point.