Research and Development Director jobs in Denver, CO

We are looking for an experienced Sr. Clinical Operations Manager, Business Development to join our team!

Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

Senior Clinical Operations Manager, Business Development serves as the primary point of contact for new study proposals, existing study change requests, and ongoing oversight of proposal, budget, and contracting timelines. In addition, this position may support industry sponsored clinical trials, Endpoint and Specialty Services activities, as well as any additional assigned projects.

Business Development Responsibilities:

• Serve as primary point of contact for new study and consulting proposals; coordinate with internal teams to prepare responses to proposals including project budgets.
• Develop and manage proposal specific timelines to ensure timely delivery of responses to clients and internal CPC team members.
• Serve as primary point of contact for the internal CPC teams to address questions about contracted scope, budget amendments, budgeted task inclusions, etc.
• Help maintain, or develop where needed,standard materials and templates for responses to proposals, bid defenses, capabilities discussions, etc. based on different business lines within CPC. 
• Work closely with Legal Affairs to ensure confidentiality agreements are in place with new partners prior to dissemination of confidential information.
• Coordinate the process for obtaining  quotes from vendors as requested by the CPC project team, or as needed to complete a new proposal budget.
• Facilitate scheduling of external meetings to review proposal requests, budget questions, capabilities presentations, etc.

Clinical Research Responsibilities:

• Work closely with the Director of Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.
• Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
• Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM).  For single-site or smaller multi-center studies in which these activities are not delegated to a CTM:

* Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.

* Identify the required regulatory documents for investigational product (IP) release and oversee documents collection.

* Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.

* Oversee the development of project-specific essential documents for site oversight and development of site materials.

* Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs).

* Work with CRAs on overall site management including identification, and resolution of site related compliance issues.

* Prepare study enrollment reports and review site issues with the project team.

* Manage and approve site payments as applicable.

• Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.
• Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations.
• Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.
• Oversee trial-related activities and provide performance feedback to supervisors for all project team members.
• Participate in the review, development and testing of study databases.
• Provide investigational product or device tracking and disposition as required by project.
• Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. 
• Identify vendors and manage vendor services.
• Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates.
• Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.
• Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks.
• Ensure the overall quality of project services and deliverables.
• Provide necessary updates and reports to the sponsor as outlined by the contract.
• Plan and oversee the execution of investigator meetings as contracted.
• Work with the business development team on budgets, proposals and change orders.
• Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
• Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. Routinely advise management regarding the overall project status.
• Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. 
• Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.
• Supervise and evaluate performance of all staff reporting to this position, if applicable.
• Additional activities as required.

Qualifications:

• A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
• 5 years of experience in a clinical research setting (required).
• 3 years of sponsor or CRO clinical research project/clinical operations management experience.
• Experience contributing to or managing new business proposals strongly preferred.
• Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other COMs.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
• Proficiency in Microsoft Office, particularly Outlook, Word and Excel.

• Excellent communication and organizational skills.
• Great attention to detail.

• Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.
• Ability to organize, instruct and supervise staff, while promoting group effort and achievement.
• Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.

• Willingness to travel 20-25% of the time.

Targeted Compensation: $95,000 - $115,000 annually

Deadline to Apply: May 1, 2024

Note: Viable applicants will be required to pass a background and education verification check.

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
• In-suite exercise and relaxation room
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.