Clinical Trial Manager - Oncology - Major Biopharma Company

MedFocus, one of the leading providers of clinical research contract consulting services, currently has an opening for a Clinical Trial Manager, to work in the Oncology division of a major biopharmaceutical company in San Diego, CA.

 

MedFocus is a respected provider of clinical research personnel to the leading pharmaceutical and biotech companies across the U.S. We provide highly competitive salary and benefit packages, candidate referral bonuses ranging from $1000-$3000, and a client base which includes every Top-20 pharmaceutical and biotech company in the industry. Visit us at www.medfocus.com to find out more about the opportunities that we currently have available.

 

Duties and Responsibilities:

The successful candidate will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report; Ensures completion of study deliverables; develops Therapeutic Areas knowledge and expertise through internal training and external conference attendance. Typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.).  Follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities.  Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Typical duties and responsibilities will include:

· Manages all clinical aspects of study including: Assesses operational feasibility and recommends study execution plan

· Develops and manages comprehensive study timelines and metrics

· Participates in selection and management of external vendors and develops vendor specifications; provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel

· Prepares and presents project debriefings, as required

· Plans, executes, and leads study-specific meetings (e.g., SMT, investigator meetings, Advisory Committee)

· Participates in site monitoring visits as appropriate.

· Uses operational and therapeutic expertise to optimize trial design and execution: Works with the SMT to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met

· Prepares study-related documentation

· Provides input for the design of the ICF, CRFs, monitoring conventions, edit checks, etc.

· Develops relationships with investigators and site staff; Selects sites and countries (with Commercial input for phase II/III).

· Works with Business Analyst to develop and manage study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget.

· Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: Participates in the planning of quality assurance activities and coordinates resolution of audit findings

· Ensures audit-ready condition of clinical trial documentation including central clinical files

· Reviews monitoring reports to ensure quality and resolution of site-related issues;

· Coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.

· Coaches and provides guidance to clinical staff (Assoc CTMs, Clinical Trial Coordinators (CTCs)).

· Daily interaction with study Medical Director and members of the cross-functional SMT. 

· Frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.). 

 

Required Experience / Education:

· Minimum of 5 years of clinical trial experience in Pharmaceutical, Biotech or CRO Company required, with a minimum of 3 years of trial management experience.

· Bachelor's degree or equivalent combination of education/experience in science or health-related field required

· Must Have Strong Oncology Experience

· Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills. 

· Also requires excellent communication, and organizational skills, along with problem solving, conflict resolution, leadership and team building skills.