Contract Clinical Program Manager 2
Clinical Operations | Berkeley, CA | Contract
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib) was the first oral targeted therapy to be approved for the treatment of both metastatic and unresectable melanomas. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and patients.
Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 70 employees based in Berkeley, California and the contract Clinical Program Manager 2 (“CPM”) will be a critical member of the Clinical Operations team reporting to the Director of Clinical Operations.
The contract CPM will manage operational strategies for designated oncology and non-oncology clinical trials of moderate complexity. The CPM will collaborate cross-functionally to ensure corporate goals and objectives are met. The CPM is expected to manage CRO, vendors, and site related issues, with supervision from Director of Clinical Operations. The ideal candidate will be an individual with strong experience in oncology clinical trials, who is comfortable being responsible for managing all aspects of the assigned clinical trials. This is a part-time contract role and we anticipate will be about 20 hours per week for likely 6 months. Ideally, the candidate will be able to be onsite 2 days a week; time on site negotiable for non-local candidates.
Responsibilities include but are not limited to:
- Manage outsourced activities and approved budgets for clinical studies, such as CROs, vendors, bioanalytical labs, and site monitoring to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements, and applicable SOPs
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Manage ‘Plextension’ studies in late maintenance phase, for which full study management (site monitoring, data management, TMF management, etc.) has been assumed from CROs.
- Contribute to relevant study documentation including clinical protocols, annual safety reports, clinical study reports, etc.
- Create and/or review study operational documents/plans (informed consent form, monitoring plan, data management plan, program management plan, etc.)
- Provide basic biometrics input to CRO, such as: participation in CRF and edit check design review; data cleaning oversight; manage CRO delivery of TLFs, datasets and associated data deliverables
- Proactively identify project risks and propose risk mitigations with some supervision
- Participate in the selection of sites, CRO, and vendors
- Participate in study data review and other review activities as assigned
- Work closely with other functions in the organization (medical science, clinical supplies, medical writing, translational medicine, regulatory, legal, finance, research)
- Support Investigator-Sponsored trials with Plexxikon investigational medicinal products.
- Represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
- Travel (less than 20%) to clinical sites for monitoring visits and/or co-monitoring may be required
- May mentor and develop junior clinical operations staff
- Other duties as assigned
Position Requirements & Experience:
- Bachelors or Masters Degree in nursing, life science, or related field (or equivalent experience)
- 8 or more years of relevant clinical trials experience in at a site, CRO, or Sponsor
- 5 or more years of clinical trial management experience in a Sponsor or CRO setting
- 3 or more years of clinical operations experience as Sponsor CRA or PM in an oncology indication preferred
- Experience and understanding of ICH and GCP
- Proven track record showing excellent clinical project management skills
- Solid vendor management skills, e.g. CRO, central laboratory, bioanalytical laboratory
- Broad understanding of clinical operations in relation to clinical development functions
- Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Ability to effectively interface with medical personnel at clinical site(s)
- Ability to lead multi-disciplinary teams both internally & externally
- Must have demonstrated problem solving abilities and strong organizational skills.
- Ability to write technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Detail and team oriented with excellent cross-functional team leadership and participation skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Plexxikon, an equal opportunity employer, is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment. To learn more about Plexxikon, please visit our website at www.plexxikon.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Please no phone calls, agencies or recruiters