Senior Clinical Research Lead

Shelby American, Inc.; Austin (TX); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading healthcare organization is seeking a Senior Clinical Research Lead to oversee project delivery and quality, ensuring financial success and compliance with regulatory standards. The role involves managing multiple projects, collaborating with stakeholders, and mentoring team members. Ideal candidates will possess strong communication, analytical, and organizational skills, with a background in life sciences and project management.

Qualifications

• 6+ years project management or equivalent experience.
• Minimum 2 years’ experience managing teams and projects.
• Experience with clinical trial master filing systems.

Responsibilities

• Manage project plans, timelines, and budgets.
• Ensure compliance with Good Clinical Practice (GCP) guidelines.
• Communicate project updates to stakeholders.

Skills

Interpersonal Skills

Communication Skills

Organizational Skills

Problem-Solving Skills

Analytical Skills

Education

BS/BA in Life Science

Tools

Clinical Trial Management System (CTMS)

Electronic Document Management System (EDMS)

MS Office

Job description

The Senior Clinical Research Lead will liaise directly between Elligo functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control for each project assigned from study award through closeout. The focus is on leveraging our patient recruitment and suite of solutions to drive operational excellence and strategic leadership with Elligo’s customers. The Senior Clinical Research Lead works collaboratively with key internal and external stakeholders to develop study specific processes, manage communication across all involved parties, create and maintain study timelines. Additionally, this role works to establish and assure the execution of project reporting schedules and assure that all stakeholders receive all project updates per the established schedule. This includes having a strong understanding of study contracts, budgets, regulatory, and fiscal management. The Senior Clinical Research Lead is assigned to manage a range of projects from small limited in scope to more-complex projects.

ESSENTIAL DUTIES:

• Reviews study requirements and response assessment criteria, collaborating with key stakeholders to execute study start-up, conduct and close-out activities according to the customer’s and company’s contractual agreements.
• Creates, maintains, and implements definitive project plans (i.e. timelines, milestones and requirements for project staff).
• Establishes and executes project reporting schedules.
• Communicates timely, appropriate project information to project teams, sites, and company/sponsor representative(s).
• Ensures the financial success of the project by forecasting and identifying opportunities to accelerate activities to bring revenue forward
• Determines resources required for project completion and communicating needs to
• Ensures projects are executed in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs), and regulatory requirements.
• Coordinates activities and deliverables of all study team members, including training.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Provides oversight for study documentation and ensuring project records remain inspection ready.
• Performs financial tasks including monthly billing, forecasting, project scope reviews and amendments, along with pass-through cost management.
• Analyzes project performance for consistency/quality within established project guidelines.
• Hosts regular project meetings with customer(s) to share key updates and current performance.
• Builds positive customer relationships with the goal of acquiring net new awarded projects.
• Identifies lessons learned and implements best practices
• Oversee the full life cycle of regulatory activities from study start-up to study closure and record retention of projects assigned to
• Key stakeholder in Quality Management, Inspection Readiness and supporting audits
• May assist in preparing proposals and budgets
• Coordinates study specific training and other requirements for internal and external staff as appropriate
• Contributes to revisions of Standard Operating Procedures, guidelines and departmental policies
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development
• Performs other duties as required and/or assigned.

QUALIFICATIONS:

• Outstanding interpersonal and client relationship skills with the ability to build and foster positive relationships.
• Excellent verbal and written communication skills, including the ability to effectively convey ideas and information with clarity.
• High attention to detail and produces accurate work.
• Strong organization/prioritization skills for the management of multiple concurrent projects with competing deadlines.
• Capacity to lead and provide direction to others.
• Ability to work with functional groups and different levels of employees throughout an organization to achieve business results effectively and professionally.
• Proactive and timely follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Self-motivated; able to work independently to complete tasks respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Data driven, systems thinker who can generate and execute ideas at strategic and tactical levels. Thrives in a fast-paced environment, integrating disparate activities, new technologies, and agendas while adhering to deadlines and budgets.
• Strong analytical and problem-solving skills with the ability to understand the big picture.
• Skilled in interacting and working with others, including peers, patients, management, and internal and external stakeholders.
• Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
• Strong knowledge in clinical trial terminology and practices required.
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
• High comprehension of HIPAA privacy and security laws and PHI
• Adaptable in a fast-paced environment with changing priorities, tasks, and client conditions.
• Strong customer service skills with an ability to work under pressure and conflicting client deadlines and requests.

EDUCATION AND EXPERIENCE:

• BS/BA in Life Science or related discipline.
• 6+ years project management or equivalent experience.
• Minimum 2 years’ experience managing teams, managing projects, and directly or indirectly facilitating workgroups
• Minimum 5 years of experience customer service experience, with at least 5 years of client relationship management experience
• Over 3 years of financial management experience, including overseeing and managing project level budgets
• Experience executing project plans, timelines, and budgets.
• Experience with clinical trial master filing systems.
• Experience working with or working for local or central IRBs/IBCs
• Experience in working in hybrid/decentralized trial models is preferred

ENVIRONMENT:

This is remote position based on the location of the incumbent’s home. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.

Less than 25% travel may be required to support the position’s responsibilities

PHYSICAL DEMANDS:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is required to:

• Regularly work at a desk using a computer for prolonged periods.
• Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
• Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
• Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.
• Occasionally move safely over uneven surfaces.
• Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.

ADDITIONAL:

Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.

The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.

The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the position’s expectations and responsibilities are met.

Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.

Requirements

BS/BA in Life Science or related discipline.

6+ years project management or equivalent experience.

Minimum 2 years’ experience managing teams, managing projects, and directly or indirectly facilitating workgroups

Minimum 5 years of experience customer service experience, with at least 5 years of client relationship management experience

Over 3 years of financial management experience, including overseeing and managing project level budgets

Experience executing project plans, timelines, and budgets.

Experience with clinical trial master filing systems.

Experience working with or working for local or central IRBs/IBCs

Experience in working in hybrid/decentralized trial models is preferred